Field of the Invention
[0001] The present invention relates generally to data processing apparatus and methods
and, more particularly, to medical monitoring apparatus and systems.
Background of the Invention
[0002] Chronic disease management conventionally involves routinely monitoring patients
who suffer from chronic disease to identify disease-related health problems before
they become medically severe. Routine monitoring is also required in patients undergoing
various forms of rehabilitation or primary prevention such as programs designed to
promote healthy diet and exercise behavior. Disease management and prevention may
also involve monitoring exercise and diet patterns of patients, as well as adherence
to and adjustments of prescribed medicine. The management of chronic disease also
often involves continuous treatment of a disease process with one or more medicines.
Many of these medications have a relatively narrow therapeutic window; that is, there
is a narrow range of medication dosages that provide optimal therapeutic effect without
producing undesirable and potentially dangerous side effects. Other, often behavioral,
factors such as illness, or changes in sleep, vitamins, diet, exercise, stress, menstrual
cycles, etc. can impact the efficacy, absorption, dissipation, bioavailability and
hence optimal dosing requirements of medication. Additionally, due to comorbid or
co-occurring diseases or intercurrent illness, there are risks related to potential
medication interactions that can also affect the efficacy dosing requirements of one
or more of the medications used in treatment. Ideally, the effects of medication should
be continuously monitored in order to insure that the patient is deriving maximal
therapeutic benefit without suffering the effects of overmedication or from potentially
dangerous interactions.
[0003] Most patient assessment of the efficacy of self-administered treatment programs such
as medication regimens, rehabilitative recovery or primary prevention occurs in the
offices of healthcare professionals. Unfortunately this is both time-consuming and
expensive, and can only partially deal with issues related to timeliness and compliance.
To overcome the disadvantages of requiring patients to visit a physician's office
for assessment of their disease or condition, various health care organizations have
implemented programs where case managers (
i.e., persons with some level of medical training) telephone patients periodically to
obtain patient data and to coordinate care. Unfortunately, with often hundreds of
patients per case manager, personal contact with individual patients on a daily or
even regular basis may be difficult. In addition, personal contact with individual
patients on a regular basis may be somewhat expensive. Accordingly, case managers
using conventional management techniques may not be able to monitor, adjust or promote
a patient's medication dosage or other treatment regimen as often as desirable or
necessary.
[0004] Another approach used in chronic disease management involves automated voice messaging
(AVM) services, wherein patients receive regular telephone calls providing various
educational and motivational messages from case managers. Exemplary messages may include
reminding a patient of a scheduled physician visit. Some AVM services involve one-way
communication, wherein a recorded message is delivered to a patient, but no information
is obtained from the patient. As a result, the medical condition of a patient may
not be available unless the patient is examined in-person by a physician.
[0005] AVM services involving two-way communications may allow patients to respond to AVM
telephone queries via a touch tone telephone. Information received from patients may
be reviewed by a case manager (CM). The CM then may identify which patients require
callbacks for gathering more detailed information, discussing problems, or providing
further information. Unfortunately, AVM services involving two-way communications
may require some level of human intervention to identify patients with medically severe
conditions that require immediate medical attention, such as a change in warfarin
or insulin dosage. Chronic disease management via AVM has another drawback in that
delays may occur between the identification of a patient with a medically severe condition
and actual treatment of the condition.
[0006] In order to assist the physician and CM in following a patient with chronic disease,
home monitoring devices have been developed and marketed that can collect physiologic
data and report this data back to the physician. Examples of such devices include
home blood glucose monitors, home blood pressure monitors, home peek-flow monitors
for asthma, and home coagulation time monitors for patients undergoing anticoagulation
therapy. While these systems can collect physiologic data at home, they do not provide
direct guidance to the patient on need changes in chronic medication dosing. They
also do not provide a convenient way for physicians to use the data generated to cost-effectively
manage patients.
[0007] In addition to case managers, AVMs, and home diagnostic devices, several systems
have been devised that collect disease-related data at home and transmit them to a
central location where the data can be analyzed by a physician or other healthcare
professionals. Such systems include DiabCare (Roche Diagnostics), The Buddy System,
Health Hero, and LifeChart. Some of these systems directly interface with home physiologic
monitors (e.g., DiabCare and LifeChart) as described above. However, all of these
systems simply collect data from remotely-located patients and present the data in
summary form. They do not attempt to help the physician or health care provider prioritize
patients in need of attention, recommend actions to ameliorate the patient's condition,
or give information back to the patient about what he or she should do in the event
the a change in the therapy regimen in indicated.
[0008] One system that has attempted to automate disease management for insulin therapy
in diabetes mellitus is the Diacare® System, described in
U.S. Patent No. 4,731,726. Unfortunately, the Diacare® System is narrowly focused on treating diabetic patients
using insulin, and lacks many of the important features of a system that would be
necessary for delivering a wide variety of interventions in a number of medical diseases
or conditions such as anticoagulation therapy.
[0009] Warfarin and other anticoagulant therapies are indicated for conditions involving
the increased likelihood of fibrin clot (thrombosis). These thromboses may increase
the likelihood of stroke, myocardial infarctions or other cardiovascular events. Anticoagulant
therapies interfere with or decrease the ability of the body to form a fibrin clot
(thrombosis). Since under-medication can result in a thrombosis, and overmedication
can result in potentially disastrous hemorrhagic complications, all of these therapies
need to be very closely monitored. Examples of these therapies and the types of tests
used to monitor them are shown in Table 1 below:
Table 1 - Anticoagulation Therapies & Tests
THERAPY |
TEST |
Warfarin and other vitamin K antagonists |
Prothrombin (PT) |
Heparin and similar glucosaminoglycans |
Partial Thromboplastin Time (PTT) |
Activated Clotting Time (ACT) |
Specific heparin or low low molecular weight heparin assays |
Direct thrombin inhibitors (e.g., hirutin, melagatgran) |
Ecarin clotting time (ECT) |
Thrombin clotting time |
PT or PTT |
[0010] PT or other coagulation tests (listed in Table 1) and regular visits to the physician
or clinic are needed to monitor anticoagulation therapy. Anticoagulation therapy is
a highly individualized matter that should be monitored closely. Numerous factors,
alone or in combination, including travel, changes in diet, environment, physical
state and medication may influence response of a patient to anticoagulants. As such,
anticoagulant dosage should be controlled by periodic determinations of prothrombin
time (PT)/International Normalized Ratio (INR) or other suitable coagulation tests.
[0011] Coagulation tests and regular visits to the physician or clinic are typically required
to effectively monitor anticoagulation therapy. Unfortunately, regular visits to a
physician or clinic can be expensive and inconvenient. In addition, patients may be
required to attend training prior to being allowed to self-administer medication and
testing regimens. Such training may be too complex and/or cost-prohibitive for many
patients.
Summary of the Invention
[0012] In view of the above discussion, it is an object of the present invention to provide
apparatus and methods that allow patients to remotely self-monitor disease therapy,
such as Anticoagulation or other therapies that can be optimized (
i.e., deliver maximum therapeutic benefit in the most cost-effective way with minimal
side effects and complications by close monitoring, and that can modify medication
regimens without requiring a patient to visit a healthcare provider.
[0013] It is another object of the present invention to allow health care providers to quickly
and easily monitor many patients and to automatically identify patients with medical
conditions that are pertinent to ongoing therapies and to organize identified medical
conditions by severity.
[0014] According to a first aspect of the present invention there is provided a method for
monitoring anticoagulation therapy of a patient, wherein the anticoagulation therapy
includes a patient-administered medication regimen selected from the group consisting
of warfarin and vitamin K antagonists, heparin and glucosaminoglycans, and direct
thrombin inhibitors, and a patient-administered regimen for a coagulation test that
monitors efficacy of the medication regimen, wherein the coagulation test is selected
from the group consisting of prothrombin time (PT) test, partial thromboplastin time
(PTT) test, activated clotting time (ACT) test, heparin assays, ecarin clotting time
(ECT) test, and thrombin clotting time test, wherein a portable apparatus is configured
to receive and analyse information regarding patient compliance with the patient-administered
medication and coagulation test regimens, and wherein the apparatus is configured
to modify the patient-administered medication and coagulation test regimens, the method
comprising the following steps performed by the portable apparatus:
receiving data from a patient, wherein the patient data includes at least one of physiological
data, pathophysiological data, biological data, psychological data, neuropsychological
data, and behavioural data;
assessing severity of the received patient data;
prompting the patient to perform a patient-administered coagulation test if the received
patient data are assessed to be above a threshold severity level;
receiving coagulation test results from the patient-administered test; and
communicating the received coagulation test results from the patient-administered
test to a healthcare provider via a communications network.
[0015] According to a second aspect of the present invention there is provided a system
for monitoring anticoagulation therapy of a patient, wherein the anticoagulation therapy
includes a patient-administered medication regimen selected from the group consisting
of warfarin and vitamin K antagonists, heparin and glucosaminoglycans, and direct
thrombin inhibitors, and a patient-administered regimen for a coagulation test that
monitors efficacy of the medication regimen, wherein the coagulation test is selected
from the group consisting of prothrombin time (PT) test, partial thromboplastin time
(PTT) test, activated clotting time (ACT) test, heparin assays, ecarin clotting time
(ECT) test, and thrombin clotting time test, wherein the system comprises:
a patient apparatus, comprising:
a processor;
a user interface in communication with the processor;
computer code executable by the processor that receives and stores data from a patient,
wherein the patient data includes at least one of physiological data, pathophysiological
data, biological data, physiological data, neuropsychological data, and behavioural
data;
computer code executable by the processor that assesses severity of the received patient
data;
computer code executable by the processor that prompts the patient via the user interface
to perform a patient-administered coagulation test if the received patient data are
assessed to be above a threshold severity level;
computer code executable by the processor that receives and stores coagulation test
results from the patient-administered coagulation test; and
computer code executable by the processor that communicates the received coagulation
test results from the patient-administered coagulation test to a healthcare provider
via a communications network.
[0016] According to a third aspect of the present invention there is provided a method for
monitoring disease therapy of a patient, wherein the disease is selected from the
group consisting of asthma, cancer chemotherapy, depression, high blood pressure,
seizure disorders, and thrombosis, wherein the disease therapy includes a patient-administered
medication regimen and a patient-administered regimen for a test that monitors efficacy
of the medication regimen, wherein a portable apparatus is configured to receive and
analyse information regarding patient compliance with the patient-administered medication
and test regimens, and wherein the portable apparatus is configured to modify the
patient-administered medication and test regimens, the method comprising the following
steps performed by the portable apparatus.
receiving data from a patient, wherein the patient data includes at least one of physiological
data, pathophysiological data, biological data, psychological data, neuropsychological
data, and behavioural data;
assessing severity of the received patient data;
prompting the patient to perform a patient-administered test if the received patient
data are assessed to be above a threshold severity level;
receiving test results from the patient-administered test; and
communicating the received test results from the patient-administered test to a healthcare
provider via a communications network.
[0017] According to a fourth aspect of the present invention there is provided an apparatus
for monitoring disease therapy of a patient, wherein the disease is selected from
the group consisting of asthma, cancer chemotherapy, depression, high blood pressure,
seizure disorders, and thrombosis, wherein the disease therapy includes a patient-administered
medication regimen and a patient-administered regimen for a test that monitors efficacy
of the medication regimen, the apparatus comprising:
a processor;
a user interface in communication with the processor;
computer code executable by the processor that receives and stores data from a patient,
wherein the patient data includes at least one of physiological data, pathophysiological
data, biological data, psychological data, neuropsychological data, and behavioural
data;
computer code executable by the processor that assesses severity of the received patient
data;
computer code executable by the processor that prompts the patient via the user interface
to perform a patient-administered test if the received patient data are assessed to
be above a threshold severity level;
computer code executable by the processor that receives and stores test results from
the patient-administered test; and
computer code executable by the processor that communicates the received test results
from the patient-administered test to a healthcare provider via a communications network.
Brief Description of the Drawings
[0018]
Fig. 1 schematically illustrates a system for monitoring, diagnosing and treating medical
conditions of a plurality of remotely located patients according to an embodiment
of the present invention.
Fig. 2 illustrates an exemplary portable patient monitor (PPM).
Fg. 3 schematically illustrates operations for monitoring, diagnosing and treating medical
conditions of a plurality of remotely located patients according to the present invention.
Fig. 4 schematically illustrates operations for obtaining data from a remotely located patient
monitoring device.
Fig. 5 schematically illustrates operations for analyzing data to identify medical conditions
of a remotely located patient.
Fig. 6 schematically illustrates operations for identifying medical conditions according
to aspects of the present invention.
Fig. 7 schematically illustrates operations for prioritizing identified medical conditions
according to aspects of the present invention.
Fig. 8 illustrates an exemplary user interface for displaying medical conditions prioritized
according to medical severity.
Fig. 9 illustrates an exemplary user interface for displaying patient-specific information.
Figs. 10A-10C illustrate exemplary user interfaces for facilitating communications with a remotely
located patient.
Fig. 11 illustrates an exemplary user interface for adjusting a medicine dosage algorithm
stored within a patient's PPM.
Fig. 12 illustrates an exemplary user interface for seeking input from other medical experts.
Fig. 13 illustrates an exemplary user interface for facilitating and tracking patient appointments
with clinic personnel or other health care providers.
Fig. 14 illustrates an exemplary user interface for removing an identified medical condition
from an active list.
Figs. 15-19 schematically illustrate operations for monitoring anticoagulation therapy via a
patient apparatus according to one embodiment, of the present invention.
Detailed Description of the Invention
[0019] The present invention now is described more fully hereinafter with reference to the
accompanying drawings, in which preferred embodiments of the invention are shown.
This invention may, however, be embodied in many different forms and should not be
construed as limited to the embodiments set forth herein; rather, these embodiments
are provided so that this disclosure will be thorough and complete, and will fully
convey the scope of the invention to those skilled in the art. The present invention
will now be described more fully hereinafter with reference to the accompanying drawings,
in which preferred embodiments of the invention are shown. Like numbers refer to like
elements throughout.
[0020] As will be appreciated by one of skill in the art, the present invention may be embodied
as a method, data processing system, or computer program product. Accordingly, the
present invention may take the form of an entirely hardware embodiment, an entirely
software embodiment or an embodiment combining software and hardware aspects. Furthermore,
the present invention may take the form of a computer program product on a computer-readable
storage medium having computer-readable program code means embodied in the medium.
Any suitable computer medium may be utilized including hard disks, CD-ROMs, optical
storage devices, or magnetic storage devices.
[0021] The present invention is described below with reference to flowchart illustrations
of methods, apparatus (systems) and computer program products according to embodiments
of the invention. It will be understood that each block of the flowchart illustrations,
and combinations of blocks in the flowchart illustrations, can be implemented by computer
program instructions. These computer program instructions may be loaded onto a general
purpose computer, special purpose computer, or other programmable data processing
apparatus to produce a machine, such that the instructions which execute on the computer
or other programmable data processing apparatus create means for implementing the
functions specified in the flowchart block or blocks.
[0022] These computer program instructions may also be stored in a computer-usable memory
that can direct a computer or other programmable data processing apparatus to function
in a particular manner, such that the instructions stored in the computer-usable memory
produce an article of manufacture including instruction means which implement the
function specified in the flowchart block or blocks. The computer program instructions
may also be loaded onto a computer or other programmable data processing apparatus
to cause a series of operational steps to be performed on the computer or other programmable
apparatus to produce a computer implemented process such that the instructions which
execute on the computer or other programmable apparatus provide steps for implementing
the functions specified in the flowchart block or blocks.
[0023] Accordingly, blocks of the flowchart illustrations support combinations of means
for performing the specified functions, combinations of steps for performing the specified
functions and program instruction means for performing the specified functions . It
will also be understood that each block of the-flowchart illustrations, and combinations
of blocks in the flowchart illustrations, can be implemented by special purpose hardware-based
computer systems which perform the specified functions or steps, or combinations of
special purpose hardware and computer instructions.
[0024] Computer program for implementing the present invention may be written in various
object-oriented programming languages, such as Delphi and Java
®. However, it is understood that other object oriented programming languages, such
as C++ and Smalltalk, as well as conventional programming languages, such as FORTRAN
or COBOL, could be utilized.
System Overview
[0025] Referring now to
Fig. 1, a system
10 for monitoring, diagnosing, and treating medical conditions of remotely located patients
with various chronic illnesses, recording to the present invention, is schematically
illustrate. A plurality of remote or preferably portable patient monitors (PPMs)
12 are configured to establish communications directly with a central data processing
system referred to as a Physicians Access Center server (hereinafter "PAC server")
14 via communications links
13. It is noted that a majority of the functionality provided by a PPM as described herein
for many disease applications can be achieved using remote data terminals or internet
browsers, which are not necessarily portable, but which can provide personal healthcare
advice via connection to a properly configured database server system that supports
the features of a PPM described below.
[0026] A plurality of case manager clients (CMCs)
16 are configured to establish client-server communications with the PAC server
14 via a computer network
17, such as the Internet or an Intranet. The term "CMC" can be considered as a synonym
for professional or paraprofessional healthcare providers. It is understood that a
CMC or PAC server or other apparatus configured to execute program code embodied within
computer usable media, operates as means for performing the various functions and
carries out the methods of the various operations of the present invention. It is
also understood that the present invention may be used with various client-server
communications protocols, and is not limited to specific protocols such as TCP/IP
protocol.
[0027] Each of these components will be described in detail below. The present invention
will be described throughout this disclosure with respect to the control of warfarin
therapy for patients undergoing anticoagulation therapy. However, it is to be understood
that the present invention may be utilized with a wide variety of medical therapies
including, but not limited to, antiseizure therapy, cancer chemotherapy, renal failure
therapy, congestive heart failure therapy, asthma therapy, high blood pressure therapy,
attention deficit disorder therapy, depression therapy, and therapies for other chronic
diseases and conditions.
[0030] A PPM may incorporate physician-prescribed algorithms for calculating medicine dosages
for various chronic illnesses. Alternatively, a PAC server may implement a medication
dosage algorithm for anticoagulation therapy, based on values communicated to the
PAC server by a PPM, and communicate results directly to the patient. PAC server implemented
dosage algorithms may be a logical alternative to having medication dosage algorithms
stored within PPMs when medication dosage changes are infrequent.
Remote or Portable Patient Monitors (PPM)
[0031] A PPM (
12 in
Fig. 1) serves as primary means for collecting data from a patient and as means for case
managers to interface with a patient. Exemplary features of a PPM for use in accordance
with the present invention are summarized below in Table 2.
Table 2
- |
Small and portable so patient can carry around. |
- |
Data processing capabilities and built-in modem or attachable external modem. |
- |
Collects data from blood, breath or bodily fluids or other functions. |
- |
Collects patient supplied data on health status, compliance with a medical treatment
or management regimen, and psychological data. |
- |
Allows two-way communication with PAC server. |
- |
Analyzes patient data collected and delivers pre-recorded or calculated responses
and/or medication dosage recommendations based on physician instructions loaded in
PPM. |
- |
Downloads patient data to PAC server at specified time intervals or in real time. |
- |
Receives messages, updates to physician instructions and prescription dosage parameters,
dosage algorithms, fixed or contingent self-monitoring schedules, words of encouragement
or other feedback from PAC server. |
[0032] Patient data collected via a PPM may include physiologic or biologic data and behavioral
data (e.g., assessments related to diet, exercise, stress, mental status or the presence
of intercurrent illness). A PPM may also monitor patient medication intake (e.g.,
warfarin dosage). A PPM, depending on the chronic illness of the patient, may contain
software specifically designed for a particular patient's illness. For example, a
PPM for an anticoagulation therapy patient may contain physician-prescribed warfarin
dosage algorithms. It is understood that other medications, well known by those of
skill in the art, may be utilized in anticoagulation therapy in addition to, or in
lieu of, warfarin.
[0033] A PPM designed for a patient can store various data along with other relevant self-monitoring
patient data. Blood from a pricked finger may be read on a chemically treated strip
via the PPM. Automated warfarin adjustment algorithms with physician-prescribed parameters
can be stored within each patient's PPM for real-time analysis and adjustment of a
patient's warfarin dosage. The PPM may be configured to make automatic adjustments
to a patient's self-monitoring and treatment regimen based on patient-entered data
as will be described below. A PPM may also contain a database to help patients evaluate
the effects of new medications on their target disease or to provide other disease-specific
information to patients.
[0034] With respect to medications, the term "regimen" is intended to be synonymous with
a schedule for taking medication. However, it is understood that some medications
are taken in different doses on different days (or other time periods). Thus, the
term "regimen" also refers to dosage amounts of a medication taken according to a
particular schedule. Thus, the term "modifying a medication regimen" may include changing
a schedule for taking a medication and/or changing a dosage amount of a medication.
With respect to tests for monitoring the efficacy of medication in disease therapy,
the term "regimen" is intended to be synonymous with a schedule for taking a test.
Thus, the term "modifying a test regimen" may include changing a schedule for administering
a test.
[0035] Patients are responsible for recording data within their PPMs and transmitting the
data to a PAC server on a regular basis. Preferably, transmission of data to a PAC
server is highly automated and substantially "hands-off" for a patient. A patient
preferably can plug a PPM into a standard telephone jack and, with the press of a
button, establish communications with a PAC server. Each PPM may have the ability
to prompt patients when data transmissions are required, and to initiate and complete
data transmissions using an alarm-driven timer.
[0036] Preferably, each PPM contains a user interface for displaying text, graphics, prompts
and various other information. A PPM user interface serves as the primary means of
communication between the PAC server and the patient. A PPM may also be configured
to notify patients of transmission schedules to the PAC server; to notify patients
having emergency medical conditions to promptly seek medical attention; and to provide
motivational feedback to patients based upon past performance (
e.g., reward patients for keeping on schedule with data recordings and transmissions
of data to a PAC server).
[0037] Referring now to
Fig. 2, an exemplary PPM
20 is illustrated. The illustrated PPM
20 includes a display
22 and a keyboard
24. The PPM
20 also preferably includes the following which are not shown: internal, non-volatile
data storage, internally stored medication monitoring software, and a data processor
for performing various functions and for communicating with a PAC server. Internal
software (program code) may query a patient for various information via display
22. Preferably, the PPM internal software is menu-driven for ease-of-use by patients.
Preferably, the menus are written in various languages including a children's version
incorporating game-like features.
[0038] Preferably, all data entered within a PPM
20 is stored with date and time information and can be alarm initiated (
i.e., a patient or PPM can be prompted to perform a task or function). Preferably, the
PPM internal software analyzes the entered data and continuously informs the patient
of his/her prescribed medication dose. The PPM internal software can calculate adjustments
for a patient's medication dosage according to a physician's prescription as applied
to the data entered into the PPM by the patient.
[0039] The internal software of a PPM can be configurable by a case manager via a PAC server.
A case manager can make adjustments to a patient's medication dose calculations, to
a patient's dosage algorithm, and to a patient's fixed or contingent self-monitoring
schedules. These adjustments can be made automatically within a PPM during routine
data transfer to a PAC server. In addition to providing disease therapy management,
a PPM can be used to remind patients to schedule appointments for important examinations.
[0040] Preferably, a PPM contains a database of medication interaction information and is
configured to allow a patient to query the database for information related to the
patient's use of multiple medications. A PPM may be configured to communicate with
an external database containing medication interaction information, as well. For example,
a patient may query a database located within a PAC server when communications are
established between the PPM and the PAC server. A PPM may also be configured to allow
a patient to establish communications with other external databases, such as those
residing in various legacy systems.
[0041] Other features of a PPM which are not illustrated, but which may be included, are
PCMCIA slots for connecting a PPM to various peripheral devices; RJ11 connections
to land line telephone systems; and infrared ports for communications with peripheral
devices. Additional PPM features for diabetes patients are disclosed in
U.S. Patent Number 4, 731, 726.
[0042] PPMs, according to the present invention, are not limited to land line telephone
communications with a PAC server. PPMs may communicate with a PAC server using various
communications technologies, without limitation. For example, a PPM may incorporate
wireless communications technology for communicating with a PAC server. A PPM may
also incorporate direct satellite communications technology for communicating With
a PAC server.
Physician Access_Center Server
[0043] Data entered into a PPM (
12 of
Fig. 1) by a patient is transferred to a central data processing system
14 (referred to hereinafter as a PAC server) via a telephone and modem. It is understood
that a PAC server
14 may be one or more data processing devices arranged in a network. Preferably, a direct
communications connection is established between a PPM 12 and a PAC server
14. Alternatively, an indirect communications connection may be established between a
PPM
12 and the PAC server
14 via the Internet or other network. A communications server is preferably utilized to
handle inbound and outbound communications between a PPM
12 and the PAC server
14, as would be understood by those skilled in the art of client-server communications.
The term PAC server, as used herein, includes databases for storing and manipulating
patient data as well as other server functions including, but not limited to web servers,
application servers, e-mail servers, fax servers, AVM servers, and the like. A particularly
preferred PAC server utilizes an Intel based processor running Windows NT Server 4.0
as its operating system. Preferably, a PAC server
14 is configured to handle more than 250,000 patients with at least 500 concurrent client
connections. However, a PAC server
14 may be implemented using other processors and via other computing devices, including,
but not limited to, mainframe computing systems and mini-computers.
[0044] A PAC server
14 analyzes and stores data transmitted from each patient PPM
12. This data is made available to authorized case managers who can access the data via
a CCM
16 in TCP communication with a PAC server
14 via the Internet. In particular, a PAC server
14 identifies and prioritizes patient medical problems using the data transmitted from
the patient PPMs
12. This allows case managers to focus their attention first on patients with significant
medical problems.
[0045] Preferably, a PAC server
14 performs real-time analysis on data as it is being transmitted from a PPM to identify
medical emergency situations that require immediate attention. If such a medical emergency
is identified, a patient can be immediately notified via communications from a PAC
server
14 to a PPM
12, without the intervention of a case manager. Alternatively, a case manager can be
notified and the patient contacted directly via phone, e-mail, fax, or other modes
of communication.
[0046] A PAC server
14 performs various other functions including allowing case managers to change the treatment
program for patients, such as medication dosage, when a patient downloads data to
a PAC server
14. In addition, a PAC server may include a "tickler system" for reminding case managers
to verify that communications with patients have occurred and for verifying that medical
conditions requiring medical attention have been resolved. A PAC server may also be
configured to track patient medication supply usage automatically (
e.g., warfarin, lancets, and syringes) and this information may be used to provide just-in-time
delivery of replacement medications and supplies to a patient. A PAC server may be
configured to communicate with manufacturers and distributors of medical supplies
utilized by patients. By monitoring patient usage of supplies, orders can be placed
with manufacturers and distributors directly via a PAC server such that medical supplies
can be delivered to patients.
[0047] A separate warehouse database may be added to a PAC server
14 to support complex analysis of patient data, and may also be used to review prescriptive
changes made to a patient's medical regimens and medication dosages.
Case Manager Clients
[0048] As illustrated in
Fig. 1, case managers access a PAC server
14 via a case manager client (CMC)
16 connected to the same network. The CMC 16 preferably communicates with a PAC server
14 using TCP/IP protocol over an Internet connection between the CMC and the PAC server.
Data encryption may be utilized and other security methods may be implemented to transfer
information between a PPM and PAC server and between a CMC and the PAC server or a
PPM.
[0049] Exemplary devices which may serve as CMCs
16 for purposes of the present invention may include, but are not limited to, desktop
computers and portable computing devices, such as personal digital assistants (PDAs).
A CMC
16 preferably includes a central processing unit, a display, a pointing device, a keyboard,
access to persistent data storage, and an Internet connection for connecting to the
Internet
17. An Internet connection may be made via a modem connected to traditional phone lines,
an ISDN link, a T1 link, a T3 link, via cable television, via an ethernet network,
and the like. An Internet connection may be made via a third party, such as an "Internet
Service Provider" ("ISP").
[0050] An Internet connection may be made either by a direct connection of a CMC to the
Internet or indirectly via another device connected to the Internet. In the latter
case, a CMC is typically connected to this device via a local or wide area network
(LAN or WAN). Preferably, data transfer rates between a CMC and a PAC server are equal
to, or greater than, fourteen thousand four hundred baud (14,400 baud). However, lower
data transfer rates may be utilized.
[0051] Preferably, a CMC 16 has an Intel@ 80486 processor (or equivalent) with at least
eight megabytes (8 MB) of RAM, and at least five megabytes (5 MB) of persistent computer
storage for caching. Even more preferable is an Intel® Pentium® processor (or equivalent).
However, it is to be understood that various processors may be utilized to carry out
the present invention without being limited to those enumerated herein. Although a
color display is preferable, a black and white display or standard broadcast or cable
television monitor may be used. A CMC
16, if an IBM®, or IBM-compatible personal computer, preferably utilizes either a Windows®3.1,
Windows 95®, Windows NT®, Unix®, or OS/2® operating system. However, it is to be understood
that a terminal not having computational capability, such as an IBM® 3270 terminal
or a network computer (NC), or having limited computational capability, such as a
network PC (Net PC) may be utilized in accordance with an embodiment of the present
invention for accessing the Internet in a client capacity.
[0052] Herein, the term "Internet" shall incorporate the term "computer network" and "communications
network" such as an "Intranet", and any references to accessing the Internet shall
be understood to mean accessing a hardwired computer network as well. Herein, the
terms "computer network" and "communications network" shall incorporate publicly accessible
computer networks and private computer networks, and shall be understood to support
modem dial-up connections.
[0053] A case manager accesses a PAC server
14 via a CMC
16 to review the medical conditions of multiple patients. Case managers preferably are
able to review, via information downloaded from a PAC server
14, all patient activity and data for their assigned patients including data transmission
history, symptom reports, prescription review, analysis and adjustment. A CMC
16 allows a case manager to review patient data in various formats, including a hierarchical,
problem-oriented format wherein patients with medical conditions requiring immediate
attention are presented foremost. A CMC
16 may also allow a case manager to add, edit, and delete certain patient data stored
in a PAC server
14. A CMC
16 also can interface directly with each PPM
12 to provide a patient with information and to modify illness-specific software contained
therein. For example, a warfarin or other anticoagulation dosage algorithm contained
within the internal software of a particular patient's PPM can be modified remotely
by a case manager via a CMC
16.
System Security
[0054] Access to a system for monitoring, diagnosing, and treating medical conditions of
remotely located patients with various chronic illnesses, according to the present
invention, may be controlled using logon security which provides case managers and
other users with certain circumscribed privileges to examine and/or edit data. These
rights can limit certain users ability to examine confidential clinical health data,
and may also be employed to limit the ability to edit any clinical data or make changes
to specific fields in a patient's medication dosages or dosage adjustment algorithm.
Similar access control may be applied to the data, at various levels, which define
patients' medical conditions and their associated priorities and pre-emptive relationships.
[0055] Flexible configuration and associated security may be an element of a system for
monitoring, diagnosing, and treating medical conditions of remotely located patients,
according to the present invention, that permeates many of the subsystems. Default
values and classifications for many values may be provided at the system level. Default
values may be modified in a hierarchical manner, and may be controlled in part by
access rights of a user, to a permit uniqueness at various levels.
Operations
[0056] Referring now to Fig. 3, operations for monitoring, identifying, prioritizing and
treating medical conditions of patients with chronic illnesses, according to the present
invention, are schematically illustrated. Patient data are obtained by a PAC server
from a PPM (Block
100). A PAC server analyzes the obtained data to identify patients with medical conditions
requiring treatment or some type of medical attention (Block
200). A PAC server prioritizes the identified patient conditions according to medical
severity (Block
300). A PAC server displays to a case manager (or other user), via a client in communication
with the PAC server, a selectable list of patients with identified medical conditions
arranged in priority order (Block
400). A PAC server provides to a case manager, via a client, options for treating each
identified medical condition (Block
500). Physician-prescribed medication dosage algorithms may be implemented based on patient
data obtained from a PPM (Block
600). Treatment information may be communicated directly to a patient or to a patient's
PPM by a case manager via a client in communication with a central data processing
system (Block
700). The operations set forth in
Fig. 3 are described in detail below.
Obtaining Data From PPM
[0057] In a preferred embodiment, when a PAC server obtains patient data from a PPM (Block
100), operations schematically illustrated in
Fig. 4 may be performed. Preferably, data transmitted to a PAC server is analyzed substantially
simultaneously with transmission of the data for the purposes of identifying "emergency"
medical conditions requiring immediate medical attention (Block
102). Preferably, this analysis is performed while communications are still established
between a PAC server and a PPM transmitting the data. If emergency medical conditions
are not identified (Block
104), data obtained from a PPM is stored within a PAC server database for later analysis
and retrieval (Block
110).
[0058] If emergency medical conditions are identified (Block
104), instructions are downloaded to the PPM regarding what actions should be taken by
the patient (Block
106). For example, the patient may be instructed to immediately take a specific medication
or to immediately seek medical attention. If a medication dosage algorithm is stored
in a PAC server, the PAC server may communicate a new medication dose to the PPM,
or to the patient via telephone, AVM, e-mail, facsimile transmission, and the like.
In addition, changes may also be made to medicine dosage algorithms stored within
a PPM or within the PAC server, such that a patient's next dose of medicine is changed
in response to the identified emergency medical condition. Furthermore, changes may
also be made to a patient's fixed or contingent self-monitoring schedules. The next
scheduled time for data transmission from the PPM to the PAC server may be set, based
on an identified medical condition's severity, such that higher condition severities
result in more frequently scheduled transmissions (Block
108). For example, PPMs for patients with asthma may be reprogrammed to transmit every
12 hours, while PPMs for patients with high blood pressure may be adjusted to transmit
every 3 days, while patients with no identified conditions may transmit on a routine
schedule such as every week. The data obtained from a PPM is then stored within a
PAC server database for later analysis and retrieval (Block
110).
Analysing Patient Data to Identify Patients With Medical Conditions Requiring Medical
Attention or Treatment
[0059] Referring now to
Fig. 5, preferred operations for analyzing patient data transmitted from a PPM to a PAC server
to identify medical conditions requiring medical attention or treatment are schematically
illustrated. Initially, operations for identifying medical conditions from transmitted
data (Block
202) are performed. Exemplary operations represented by Block
202 are schematically illustrated in
Fig. 6, and are discussed below.
[0060] Still referring to
Fig. 5, if medical conditions requiring attention are not identified from data transmitted
from a PPM (Block
250), a determination is made whether there are any unresolved medical conditions for
the patient requiring attention or treatment (Block
252). If there are no unresolved medical conditions, case managers may provide patients
with positive feedback to reinforce their self-monitoring practices and encourage
continued compliance with the treatment regimen(s) (Block
254). Additionally, patients with chronic diseases must have regularly scheduled reviews
and assessments, with the latter performed predominantly in the clinic. Periodic comprehensive
reviews of the patients can be performed and may utilize all available inputs, including
the most recent month's PPM data. These periodic assessments may be flexibly scheduled
depending upon the disease and/or disease state of individual patients. These reviews
provide a structured means by which the case manager may work to optimize care for
patients who otherwise are not specifically identified as having medical conditions
that require treatment, but who nonetheless can benefit by feedback and further optimization
of medication doses, algorithmic methods for adjusting doses, self-monitoring schedule
and by coordinating medical assessments and procedure conducted by other medical specialists.
[0061] If medical conditions are identified (Block
250) from transmitted data from a PPM, or if there are unresolved medical conditions
for the patient (Block
252), a determination is made whether a medical condition requires additional patient
input (Block
256). If patient input is required, the patient is notified by various methods, such
as via telephone, e-mail, AVM, facsimile transmission, or via the patient's PPM (Block
258). Preferably, the present invention includes a "tickler" system for monitoring whether
a patient provides required input within a specified time period (Block
260). If a patient does not provide required input within a specified time period, the
present invention may prompt a case manager to re-notify a patient of required input
(Block
258).
[0062] If input from a patient is not required (Block
256) or if patient input has been received (Block
260), a case manager is provided with various options for resolving one or more medical
conditions. A case manager may be presented with an option to contact a patient (Block
262). If a case manager decides to contact a patient, the present invention facilitates
communication via telephone, e-mail, AVM and facsimile transmission (Block
272). A case manager may be presented with an option to adjust a medicine dosage algorithm,
a patient's dosage, or a patient's fixed or contingent self-monitoring schedule, either
within a patient's PPM or the PAC server (Block
264). If a case manager decides to adjust a medicine dosage algorithm within a patient's
PPM, the present invention facilitates this modification though a PAC server the next
time communications are established between the PAC server and the patient's PPM (Block
274). A patient may be prompted to establish communications between his/her PPM and a
PAC server to receive modifications made by a case manager. Alternatively, if a medicine
dosage algorithm resides within a PAC server, a case manager can instruct the PAC
server to adjust medicine dosage and transmit this information to the patient.
[0063] In addition, a case manager may be presented with an option to schedule a patient
for a visit with a health care provider (Block
266) or with an option to seek expert medical input (Block
268). If these options are selected, the present invention facilitates scheduling a patient
to visit a health care provider (Block
276) or obtaining input from a medical expert (Block
278). A case manager may decide that no action is required for a particular medical condition
and may remove an identified medical condition from an active medical condition list
for a particular patient after reviewing available data (Block
270).
[0064] Referring now to
Fig. 6, exemplary operations performed by a PAC server for identifying medical conditions
requiring medical attention or treatment are schematically illustrated. Preferably,
these operations are performed by a PAC server immediately after transmission of data
from a PPM to the PAC server. For any given chronic disease, there may be relationships
between medical conditions that a patient may have. For example, a patient afflicted
with thrombosis may exhibit two medical conditions having differing degrees of medical
severity. One medical condition may have a high degree of medical severity requiring
immediate attention. The other medical condition may have a much lower priority and
may not require immediate medical attention. When multiple medical conditions are
identified, two or more of these conditions for a given patient may represent problems
of a similar type which differ only in severity (as defined by the system implementation).
Conditions of lesser severity of the same type may be ignored (if identified) or may
not be identified in the first place, if a condition of the same type at a higher
priority has already been identified. It is presumed that identification and treatment
of the most severe condition identified will obviate the needs to identify or treatment
less severe conditions of the same type. Two methods are presented for achieving this
aim below.
[0065] The present invention facilitates identifying and addressing medical conditions having
the highest degree of medical severity first by organizing possible medical conditions
for a given chronic disease into various classifications and by prioritizing medical
conditions within each classification. Classification and prioritization within classes
are illustrated below with respect to Table 3.
Table 3
CLASS |
MEDICAL CONDITION |
PRIORITY |
SUB_PRIORITY |
1 |
A |
1 |
A |
1 |
A |
1 |
B |
1 |
A |
1 |
D |
1 |
A |
1 |
L |
1 |
A |
1 |
Q |
1 |
B |
2 |
A |
1 |
B |
2 |
D |
1 |
B |
2 |
F |
1 |
B |
2 |
M |
1 |
B |
2 |
Q |
1 |
B |
2 |
Z |
1 |
C |
3 |
A |
1 |
C |
3 |
B |
1 |
C |
3 |
S |
1 |
C |
3 |
U |
2 |
D |
1 |
A |
2 |
D |
1 |
B |
2 |
D |
1 |
C |
2 |
D |
1 |
F |
2 |
E |
2 |
A |
2 |
E |
2 |
C |
2 |
E |
2 |
F |
2 |
F |
3 |
A |
2 |
F |
3 |
D |
2 |
F |
3 |
F |
2 |
F |
3 |
Z |
3 |
G |
1 |
A |
3 |
G |
1 |
B |
3 |
G |
1 |
D |
3 |
H |
2 |
A |
3 |
H |
2 |
B |
3 |
H |
2 |
C |
3 |
H |
2 |
D |
[0066] The column entitled Sub_Priority presents medical conditions within each unique combination
of class and medical condition (already sorted by priority with a class) in a sorted
order that is defined expressly for each combination. That is, sub_priority provides
a means by which the conditions in the list can be further sorted to provide additional
information related to urgency. For example, problems related to late data transmissions
(all within one class and assigned to have one priority) may be displayed in the order
of the most overdue first. Subpriorities for each medical condition will be uniquely
defined for that condition. In this example, the column labeled sub_priority may be
conceived of as representing a "priority score" that can be defined for each condition.
Other embodiments may utilize different methods to achieve similar means, and the
process of prioritization could also be extended to additional levels as needed (
i.e., sub-sub-priorities). Use of a single sub_priority column will support this feature.
[0067] Using Table 3, a relationship table may be derived to determine which medical conditions
have a higher degree of medical severity than other medical conditions. An exemplary
relationship table is illustrated below as Table 4. Conditions may be overridden that
are either 1) unrelated but of a lesser priority than those in the first column, or
2) closely related or being of the same "type" and therefore need not be identified
and treated since treatment for the most severe form will obviate the need for treatment
of less severe conditions of the same type.
Table 4
Medical Condition |
Overrides Medical Condition |
A |
D and H |
B |
G |
D |
H |
E |
F and G |
[0068] Referring back to
Fig. 6, operations for identifying medical conditions (Block
202) based upon Table 3 and Table 4 above are schematically illustrated. Initially a
test is performed for medical condition A (Block
204). If transmitted data from a PPM indicates that a patient has medical condition A
(Block
206), then tests for medical conditions D and H (Block
208 - Block
214) are not performed because medical conditions D and H have lower priority than medical
condition A. If transmitted data from a PPM indicates that a patient does not have
medical condition A (Block
206), a test for medical condition D is performed (Block
208). If transmitted data from a PPM indicates that a patient has medical condition D
(Block
210), then tests for medical condition H (Block
212 - Block
214) are not performed because medical condition H has lower priority than medical condition
D. If transmitted data from a PPM indicates that a patient does not have medical condition
D (Block
210), a test for medical condition H is performed (Block
214).
[0069] Whether or not transmitted data from a PPM indicates that a patient has medical condition
H (Block
210) or if a patient has medical condition A (Block 206), a test for medical condition
B is performed (Block
216). If transmitted data from a PPM indicates that a patient has medical condition B
(Block
218), then tests for medical condition H (Block
220 - Block
222) are not performed because medical condition H has lower priority than medical condition
B. If transmitted data from a PPM indicates that a patient does not have medical condition
B (Block
218), a test for medical condition H is performed (Block
220).
[0070] Whether or not transmitted data from a PPM indicates that a patient has medical condition
H (Block
222) or if a patient has medical condition B (Block
218), a test for medical condition C is performed (Block
224). Whether or not transmitted data from a PPM indicates that a patient has medical
condition C (Block
226), a test for medical condition E is performed (Block
228).
[0071] If transmitted data from a PPM indicates that a patient has medical condition E (Block
230), then tests for medical conditions F and G (Block
232 - Block
238) are not performed because medical conditions F and G have lower priority than medical
condition E. If transmitted data from a PPM indicates that a patient does not have
medical condition E (Block
230), a test for medical condition F is performed (Block
232). If transmitted data from a PPM indicates that a patient has medical condition F
(Block
234), then tests for medical condition G (Block
236 - Block
238) are not performed because medical condition G has lower priority than medical condition
F. If transmitted data from a PPM indicates that a patient does not have medical condition
F (Block
234), a test for medical condition G is performed (Block
238). All medical conditions identified are then stored within a PAC server (Block
240).
[0072] It should be further noted that the definition and specification of these medical
conditions and their associated priorities, and of the relationship between conditions
where the treatment and identification of lower priority condition may be superceded
by those of higher priority is configurable. The problem definitions may be configured
in part to reflect individual patient differences by adjustment of the default physiologic
or behavioral parameters which will trigger the identification of a given problems.
Where default values for identification are utilized, patient parameters are inherited
from the doctor, and these may in turn be inherited from other, hither levels within
the system.
Prioritizing Identified Patient Medical Condition
[0073] According to a preferred embodiment of the present invention, identified patient
medical conditions are prioritized based on a hierarchy of medical severity. In general,
three classes of medical conditions (Class I, II and III) may be utilized. However,
it is to be understood that various numbers and types of classes of medical conditions
may be utilized.
[0074] Class I medical conditions are those that require immediate attention based on physiologic
or behavioral data collected by a PPM. Although identified by a PAC server, many of
these conditions may.also be identified by a PPM and may result in prompts to the
patient to transmit to a PAC server up-to-date data and to follow this up with a telephone
call to the case manager or physician. While late transmissions may not necessarily
require immediate action, they may be placed in the Class I category for reasons of
health safety.
[0075] Class II medical conditions may be significant medical conditions, but may not require
immediate medical attention or action on the part of a case manager. Class II medical
conditions, if not addressed, may develop into Class I medical conditions that do
require immediate attention.
[0076] Class III medical conditions are defined as suboptimal conditions in which room for
patient improvement may be indicated by physiologic and/or behavioral data collected
from a patient's PPM. Many Class III medical conditions may relate to poor or inconsistent
compliance with a self-monitoring regimen.
[0077] Referring now to Fig. 7, operations for prioritizing identified medical conditions
according to aspects of the present invention are schematically illustrated. Identified
medical conditions are sorted by patient, medical condition, classification, priority
and sub-priorities (Block 302). Medical conditions of lesser severity for each patient
within each medical condition classification are eliminated (Block
304).
Displaying Selectable List of Patients With Identified Problems in Priority Order
[0078] After all medical conditions have been identified, a list of medical conditions for
each patient is normalized to eliminate medical conditions of the same type or of
lesser severity. Only the remaining medical conditions for a given patient are available
for display in a larger list(s) of medical conditions identified for all patients.
Fig. 8 illustrates an exemplary user interface
30 wherein a list
31 of medical conditions for a plurality of patients is displayed in priority order.
In the illustrated user interface
30, the patient with the highest priority medical condition is listed first. A filter
allows a user (case manager) to display various levels of detail of prioritized medical
conditions. A box
32 is provided in the illustrated user interface
30 that allows a case manager to select the level of displayed detail. In the illustrated
user interface, the filter selection in box
32 allows all identified, prioritized medical conditions of all patients to be displayed.
[0079] A list of prioritized medical conditions appears when a case manager first logs into
a PAC server via a CMC. The order of presentation is based on medical condition class.
Within each class, medical conditions of different types are sorted by an assigned
priority. Within each separate medical condition the individual cases are optionally
sorted by a severity index. This feature may be defined separately for each type of
medical condition, and further may reflect settings that are defined for individual
patients as necessary or desirable. For example, late transmissions may be sorted
by the number of days overdue, and persistent poor control might be sorted by blood
pressure which is chronically elevated.
[0080] Preferably, medical conditions having the highest medical severity appear at the
top of the list. Selection of a patient medical condition, such as by mouse click,
results in a change of the user interface to one focused upon the selected patient,
as illustrated in
Fig. 9. In the illustrated interface user
34 of
Fig. 9, all current medical conditions
35 for the selected patient appear on the left side
36 of the user interface
34 in a list format resembling a directory structure, and the right side
37 of the user interface contains current prescriptive and report data. The listing
on the left side resembles a directory structure in form and function, whereby selection
of a condition by mouse click will expand the list on the left side to reveal available
treatment options for the selected condition. On the right side default screens are
available in a tabbed format that can be used to modify medication dosages, parameters
related to the adjustment of medication in the PPM, and the fixed and contingent self-monitoring
schedule. Changes to these parameters can be directly communicated to the PPM and
are summarized in documentary form in a Chart Summary Report. This report and the
changed data can also be used, in part, to generate AVM using text to speech technology
that verbally summarizes new treatment instruction for the patient. Certain actions
or treatment options which may appear below current medical conditions identified
for this patient may cause other user windows and dialog boxes to appear, as described
below.
Providing Options for Treating Identified Medical Conditions
[0081] The selection of a patient medical condition in the user interface of
Fig. 9 by mouse click may result in an expanded list of available actions that may be taken
for the chosen medical condition. The actions displayed may be only those which have
been associated with the specifically-defined (and "expanded") medical condition.
Selection of an action for a given medical condition may provide immediate access
to user interfaces where dosages or algorithmic alterations can be made (if applicable),
or may provide methods for contacting patients.
Communicating Treatment Information to Patient
[0082] A variety of specific actions may be undertaken which involve or utilize a patient's
PPM. These may include the adjustment of medication dosage level or the timing for
administration; adjustment of the rules or algorithmic parameters which a PPM or PAC
server uses to independently adjust and alter medication dosage (e.g., alteration
of the target range for the physiologic function being monitoring); alteration of
the patient's self-monitoring schedule; or alteration of the parameters that trigger
additional or contingent self-monitoring suggestions in the PPM. In addition to these
parameters, a case manager may also select and/or compose messages to be downloaded
to a patient's PPM, or transmitted via telephone, AVM, e-mail and facsimile transmission,
which are designed to reinforce correct behaviors or alter maladaptive behaviors.
A case manager may also compose a message asking a patient to schedule an office visit
with a physician, and may also alter a PPM's transmission schedule (which may take
affect following the next transmission). Special messages related to scheduling office
appointments ask the patient to make an appointment with a named professional and
provide his or her phone number. The PPM may query the patient on a daily basis concerning
whether the appointment has been made, and then solicit the appointment date for uploading
to the PAC. After the appointment date has passed, the PPM can query the patient to
ascertain if the appointment was actually kept.
[0083] Preferably, screening mechanisms are provided for ensuring that treatment or information
provided by a case manager is medically qualified for a particular patient before
the treatment or information is communicated to a patient or to a patient's PPM.
[0084] Exemplary user interfaces
44a, 44b, 44c for communicating with a patient, are illustrated in Figs. 10A-10C, respectively.
In Fig. 10A, automated voice mail (AVM) messages can be selected and sent to a patient
via the box 46. In addition, personal and predefined messages can be created and/or
selected via boxes 48a and 48b, respectively, and transmitted directly to a patient's
PPM. In Fig. 10B, various written documents can be selected and sent to a patient
via the box 47. These notices can be sent via letter, fax, or e-mail, and can be personal
or predefined. In
Fig. 10C, status of communications with a patient can be monitored using various features illustrated
in box
49.
[0085] Once a change has been made in any of the above areas which utilize a patient's PPM,
a case manager may optionally elevate the new dosage prescription to a high priority.
In the present invention this may cause delivery of a voice message to the patient
that he or she should immediately initiate communications between the patient's PPM
and a PAC server in order to receive a revised treatment regimen, including, but not
limited to, modified medication doses, modified dosage algorithm(s), and modified
fixed and contingent self-monitoring schedules and parameters. If a case manager elects
not to elevate the revised monitoring parameters to a high priority level, the altered
parameters may be loaded automatically during the next routine data transmission which
is prompted by the patient's PPM according to the last transmission.
[0086] To make a newly saved prescription (
e.g., modified medication doses, modified dosage algorithm(s), and modified fixed and
contingent self-monitoring schedules and parameters) available to a patient, a case
manager "publishes" the prescription. Publishing a prescription means that an altered
prescription, which may be conveyed to a patient via a PPM, is finalized to a point
where it is officially ready to be given to the patient. An exemplary user interface
54 for adjusting a patient's physician-prescribed medicine dosage (one of several
options) via a patient's PPM is illustrated in
Fig. 11. A case manager may see up to four columns of information representing four daily
quadrants in which adjustments may be enabled for drugs like insulin that have a short
half-life. In the case of anticoagulation therapy with warfarin, adjustments in medication
are likely to be enabled once or twice per week. The adjustment parameters may appear
in a quadrant in which the medication dosage being adjusted is assessed.
[0087] In cases where case managers have questions concerning a patient's medical condition
or prescription, case managers may seek input from medical experts using a user interface
such as that illustrated in
Fig. 12. Expert input may be obtained at any step in the review and alteration process, and
may involve referencing current patient data and unresolved medical conditions (if
any) with a request for help. Expert input may be directed to a superior (
e.g., a supervising case manager or the primary care physician), a specialist or to a
collateral person involved in the patient's care (e.g., a dietitian, optician, neurologist,
hematologist, cardiologist or podiatrist).
[0088] In the illustrated user interface
50 (Fig. 12), expert input may be obtained by selecting a health care giver from the box
51. Preferably, various methods of contacting a selected health care giver are available
(e.g., telephone, fax, e-mail, office visit, and the like). Contacts with experts
may or may not be accompanied by referenced or attached patient data available from
the PAC server. Expert input can be directed to people who may not have direct access
to the PAC server and be able to directly review patient data (e.g., a podiatrist),
but are more typically directed to others with access to the system and are focused
on the patients current medical conditions and overall treatment regimen (neurologist,
hematologist, endocrinologist or primary care physician). These latter personnel may
be expected to provide either advise in written or other form, or may act directly
upon (and publish) the overall treatment regimen (medication dosages, dosage adjustment
algorithm, or the fixed or contingent self-monitoring schedule) which may be conveyed
to the Patient's PPM.
[0089] In addition to communicating with patients via a PPM, a case manager may communicate
with patients in various ways, such as via telephone, e-mail, AVM and facsimile transmission.
Preferably, the present invention provides pre-composed text for inclusion in text-based
communications such as letters, faxes and e-mail directed to a patient. Multiple selections
can be added to a letter and then edited, or the entire communication can be created
manually, and delivery of the text may be done redundantly. Telephone communications
may also be managed from a content screen where topic issues can be displayed and
optionally highlighted for documentary reasons, and a case manager may elect to immediately
make or schedule a patient call, or to schedule voice message delivery of pre-composed
or personalized text. Prompting patients to make an overdue transmission of data from
his/her PPM to a PAC server may be accomplished using voice message delivery of a
pre-composed message. Patient contact options may also be tied to a tickler system
to facilitate timely follow-up.
[0090] In addition, case managers may utilize the present invention to facilitate and track
patient appointments with clinic personnel or other providers involved in health care.
An exemplary user interface 56 for this purpose is illustrated in
Fig. 13. Once a decision is made to schedule a patient appointment, a system task reminder
may be generated that requires periodic follow-up until a record of a scheduled appointment
time is input into a PAC server. A case manager may employ a patient's PPM to prompt
the patient to make an appointment, and subsequently query the patient for the appointment
date once it has been made. Other contact methods may also be employed to prompt a
patient to make an appointment and subsequently to inform the case manager concerning
the date (
e.g., via e-mail, AVM, telephone, and facsimile transmission). A PPM may also be used
to verify appointment compliance.
[0091] Preferably, the present invention also tracks appointment compliance (e.g., whether
a patient kept his/her appointments). Healthcare providers can be sent communications
to confirm whenever an appointment has been kept by a patient and to supply associated
lab or examination data to a PAC server. To track appointment compliance with providers
who cannot directly access a PAC server, a case manager may generate correspondence
and associated follow-up reminders in order to obtain confirmation and associated
clinical data if desired.
[0092] According to another aspect of the present invention, a blind actuarial review of
changes made to the medication dosages and/or the rules utilized by a PPM to independently
adjust these doses may be utilized. Statistical analysis may optionally be performed
on published prescriptions that utilizes pattern analysis, multiple regression, time
series and other types of analyses that compare current patient data sets to earlier
data and to data of other appropriate patients. This assessment procedure is designed
to screen for potential medical conditions whose probability has markedly increased
as a result of the most recent prescriptive changes made to a patient's PPM-supported
treatment regimen. A secondary purpose involves alerting a case manager in situations
where changes made to a prescription are unlikely to result in any significant improvement
in a patient's current physiologic condition. In addition, the present invention is
also designed to focus a case manager's attention on the areas of a prescription where
intervention is likely to result in the greatest improvement in a patient's medical
condition.
[0093] When a medical condition has been corrected, it is effectively removed from a patient's
active list by use of a "Complete" button. The user interface
58 of
Fig. 14 illustrates a patient's medical condition being removed from the active list. This
is graphically illustrated by the addition a check mark in front of the medical condition.
Anticoagulation Therapy
[0094] According to another embodiment of the present invention, a portable patient monitor
(PPM) as described above may serve as a standalone device for monitoring and adjusting
patient-administered medication and testing regimens used in therapy for various diseases.
The following describes methods and apparatus for monitoring anticoagulation therapy
according to various embodiments of the present invention wherein a warfarin treatment
regimen and a prothrombin time (PT) test regimen are utilized. However, it is understood
that therapy for other diseases may be monitored in accordance with the present invention
including, but not limited to cancer, seizure disorders, depression, asthma and high
blood pressure.
[0095] Anticoagulation therapy typically includes a medication (
e.g., warfarin) regimen and a coagulation test regimen, such as a prothrombin time (PT)
test (see, TABLE 1 above for other tests), for a patient. Hereinafter, any reference
to "PT test" shall mean "coagulation test" and shall include all coagulation tests
utilized in Anticoagulation therapy.
[0096] A PPM, such as the PPM 20 illustrated in Fig. 2, and described in
US 6,024,699 when utilised to monitor disease therapy in accordance with this embodiment of the
present invention is referred to as a CoagCare" Patient Monitor (CPM). A CPM may include
all the features of a PPM described above and also includes computer code that receives
and stores patient data provided by a patient. A Palm Pilot, available from 3Com Corporation,
Santa Clara, California, may be provided with various program code to implement aspects
of the present invention.
[0097] The term "receives" is intended to include any method of receiving data including,
but not limited to, input provided via keyboard or keypad, input provided via cable
connection, input provided via infrared, RF, or other wireless connection, and the
like.
[0098] Exemplary patient information (data) may include physiological data, pathophysiological
data, biological data, psychological, neuoropsychological and behavioral data. For
example, a CPM may be configured to prompt for and receive data pertaining to hemorrhagic
and non-hemorrhagic conditions, signs or symptoms that a patient assesses, has experienced
or is experiencing currently. A CPM also may include a medication algorithm that utilizes
various patient data to modify warfarin and PT time test regimens in real time. In
addition, a CPM may include computer code that communicates modified medication and
PT test regimens to a patient. A CPM may also includes computer code that can communicate
with a remotely located data processing system, such as a PAC server described above,
and that can transmit stored patient data thereto.
[0099] A CPM may also include computer code that can prompt a patient to provide information
about the patient's compliance with a warfarin regimen and with a PT test regimen
during a preceding time period. A CPM also may include computer code that communicates
information regarding warfarin dosage to a patient in response to determining that
the patient did not comply with a warfarin regimen in a preceding time period.
[0100] Typically, a patient will interact with a CPM, such as that illustrated in
Fig. 2, on a daily basis to assess data, signs, conditions, symptoms, behaviors and compliance
with one or more prescribed medication regimens. With respect to anticoagulation therapy,
a CPM contains a PT testing schedule that can be individually prescribed via the CPM.
The CPM will prompt a patient to perform and store PT test results according to an
individualized schedule, and to test in response to certain signs, conditions, symptoms
(data as defined previously) that are evaluated by the CPM. A CPM may be configured
to prompt a patient for testing which is contingent upon self-reports of alarming
conditions, signs or symptoms (data) of either a supra-therapeutic and/or sub-therapeutic
nature).
[0101] A CPM also may include computer code that assesses changes in patient behavior that
may affect warfarin therapy on a daily (or other time period) basis. Changes in a
patient's diet, medication, illness, or vitamins are flagged for potential telephone
follow-up by a healthcare provider following the patient's next data transmission
from the CPM to a remotely located data processing system, such as a PAC server, which
was described in detail above. Patients are prompted by the CPM to indicate any warfarin
or other medication dosage additions, changes, discontinuations, or omissions. Vitamin
intake by a patient also can be assessed for impact to PT testing. Patients are also
prompted by the CPM to identify any significant dietary changes such as eating more
or less than usual, or major changes in dietary composition. Conditions that can affect
warfarin therapy, such as illness, vomiting, and diarrhea, can also be assessed by
the CPM.
[0102] Referring now to
Figs. 15-19, operations for monitoring anticoagulation therapy via a remote and preferably portable
patient apparatus (CPM) according to the present invention are illustrated. It is
understood that the present invention may be used for monitoring therapies for other
diseases and conditions including, but not limited to, high blood pressure, depression,
seizure disorders, cancer, and asthma. In the illustrated embodiment of
Figs. 15-19, the described anticoagulation therapy includes a warfarin medication regimen and
a PT test regimen. Wherever the term "warfarin" is used, it is understood that the
term "medication" may be substituted therefor.
[0103] Referring initially to
Fig. 15, a patient undergoing anticoagulation therapy logs onto his/her personal CPM (Block
1100) according to a predefined schedule (for example, a daily schedule). If the CPM determines
that information (or data) regarding the patient's warfarin and PT test regimens (or
other aspects of the anticoagulation therapy) is missing or insufficient (
i.e., that the patient has not entered this information into the CPM during a preceding
time period, or has not complied with an established warfarin regimen and/or PT test
regimen) (Block
1300), the CPM initiates a procedure for obtaining the missing patient data (Block
1350).
[0104] It is understood that missing patient data as described herein with respect to Block
1350 and
Fig. 16 is not limited to medication and test results. Missing patient data may also include
signs, conditions, symptoms, compliance with exercise regimens, confirmation of injection
sites that could affect drug absorption (heparin agents), prompts to calibrate or
test calibration of biological or physiological testing equipment, patient apparatus
maintenance, and the like.
[0105] Referring to
Fig. 16, a procedure for obtaining the missing patient data (Block
1350) regarding the warfarin and PT test regimens (or other aspects of the anticoagulation
therapy) is illustrated. The CPM prompts the patient to indicate whether the patient
took his/her prescribed dosage of warfarin in the preceding time period of interest
(Block
1351). If the patient responds "No", the CPM prompts the patient for reasons why the patient
did not take the warfarin according to the prescribed regimen and records these reasons
(Block
1356). Operations then return to Block
1353.
[0106] With respect to Block
1356, a check list is preferably provided via a user interface that allows a patient to
indicate reasons (
e.g., forgot to take medication, ran out of medication, and the like). If the patient
responds "Yes" (Block
1351), the CPM obtains information from the patient about a dose(s) actually taken and
updates a dose record(s) for the preceding time period of interest (Block
1352).
[0107] The CPM then makes a determination whether a PT test was scheduled for the preceding
time period of interest (Block
1353). If the answer is "No", operations return to Block
1400 (Fig. 15). If the answer is "Yes", the CPM prompts the patient whether the PT test was performed
(Block
1354). If the CPM determines that the PT test was not performed the CPM prompts the patient
for reasons why the PT test was not performed and records these reasons (Block
1357). The patient may also be prompted to perform the PT test at this time (Block
1357) and to enter the PT test results (Block
1355). If the CPM determines that the patient did perform the PT test (Block
1354), the CPM prompts the patient to enter the test results (Block
1355).
[0108] A determination is then made whether other data is missing (Block
1358). If the answer is "Yes", the missing data is entered, preferably on a prioritized
basis (Block
1359). If the answer is "No", operations then return to Block
1400 (Fig. 15).
[0109] Referring back to
Fig.
15, the CPM prompts the patient as to whether the patient has experienced (or is experiencing)
any supra-therapeutic signs, conditions or symptoms (collectively referred to as "data")
(Block
1400). As is well known to those of skill in the art, a supra-therapeutic sign or condition
is data which indicates a patient has taken too much of a medication (over-dose).
With respect to anticoagulation therapy, hemorrhagic "signs", such as bleeding, bruising,
thinning blood, blood in urine or stool, severe headache, other bleeding, swollen
joints, and cuts that will not stop bleeding are exemplary supra-therapeutic data.
If the answer at Block
1400 is "Yes", the CPM initiates a procedure for assessing the severity of the supra-therapeutic
signs and conditions (Block
1450).
[0110] Referring to
Fig. 17, a procedure for assessing the severity of supra-therapeutic conditions experienced
by a patient (Block
1450) is illustrated. The CPM prompts the patient to indicate supra-therapeutic conditions
that the patient is either experiencing for the first time, or that have worsened
(Block
1451). A check list is preferably provided via a user interface that allows a patient
to indicate the supra-therapeutic symptoms. The CPM makes a determination at Block
1452 whether the supra-therapeutic conditions indicated by the patient are severe and
require immediate communication to a healthcare provider. If the answer is "Yes",
information about the supra-therapeutic symptoms is communicated immediately to a
healthcare provider (Block
1453) via a communications network. The CPM may also instruct the patient to call his/her
healthcare provider immediately, or to call for emergency medical attention (Block
1454). The CPM may be configured to automatically establish voice communications with
a healthcare provider or emergency medical service for the patient.
[0111] If the answer at Block
1452 is "No", the CPM determines whether information about the supra-therapeutic signs
or conditions are serious enough to require communication to a healthcare provider
after completing the entry or interaction with the CPM;
i.e., transmissions will occur as part of this interactive session, as opposed to the
preset schedule (Block
1455). If the answer at Block
1455 is "Yes", the CPM sets a flag to transmit the supra-therapeutic data to a healthcare
provider's PAC system immediately following or at the conclusion of this entry or
interaction with the CPM (Block
156). If the answer at Block 1455 is "No", the CPM then prompts the patient to determine
whether the patient wishes to talk with a healthcare provider about the signs, conditions
or symptoms ("data" or anything else that is of concern) (Block
1457). If the answer at Block
1457 is "No", operations are returned to Block
1500 (Fig. 15). If the answer at Block
1457 is "Yes", the CPM sets a flag to transmit supra-therapeutic symptom information to
a healthcare provider following entry. (Block
1458). Operations are then returned to Block
1500 (Fig. 15).
[0112] Referring back to
Fig. 15, the CPM prompts the patient as to whether the patient has undergone any behavioral
or non-medication related changes (Block
1500). For example, has the patient changed his/her diet and/or intake of vitamins and/or
other medications. Behavioral and non-medication related changes include all signs,
symptoms, conditions and behavior (changed or otherwise of concern) that could affect
a patient's disease state, and which are not directly attributable to too much medication
(supra-therapeutic) or too little medication (sub-therapeutic). According to the present
invention, behavioral and non-medication related changes may be divided into those
that are serious (thus requiring a call to a healthcare provider immediately) and
those that bear watching. Behavioral and non-medication related changes that only
bear watching may become significant if they are deemed to alter the patient's medication
schedule or schedule for transmitting data to a healthcare provider.
[0113] If the answer at Block 1500 is "Yes", the CPM initiates a procedure for assessing
the severity of changes in or presence of behavioral factors or other conditions that
are not clearly related to supra-therapeutic or sub-therapeutic conditions (Block
1550).
[0114] Referring to
Fig. 18, a procedure for assessing the severity of changes in or presence of behavioral factors
or other conditions that are not clearly related to supra-therapeutic or sub-therapeutic
conditions (Block
1550) is illustrated. The CPM prompts the patient to indicate changes in or presence of
behavioral factors or other conditions that are not clearly related to supra-therapeutic
or sub-therapeutic conditions (Block
1551). A check list is preferably provided via a user interface. Exemplary check list
items may include whether a patient has changed vitamins/medications, whether a patient
has changed dosages of vitamins/medications, whether a patient has stopped taking
vitamins/medications, whether the patient is eating more or less, and whether the
patient is eating different foods.
[0115] The CPM then determines whether the information provided by the patient regarding
changes in or presence of behavioral factors or other conditions that are not clearly
related to supra-therapeutic or sub-therapeutic conditions requires changing (
e.g., accelerating) a testing regimen or an established data transmission schedule (Block
1552). If the answer is "Yes" the patient's testing and/or data transmission schedules
are modified (Block 1553) by the CPM. Operations return to Block
1554.
[0116] If the answer at Block
1552 is "No", the CPM determines whether the information provided by the patient regarding
changes in or presence of behavioral factors or other conditions that are not clearly
related to supra-therapeutic or sub-therapeutic conditions are severe enough to warrant
immediate transmission to a healthcare provider (Block
1554). If the answer is "Yes", the information provided by the patient regarding changes
in or presence of behavioral factors or other conditions that are not clearly related
to supra-therapeutic or sub-therapeutic conditions is immediately transmitted to a
healthcare provider (Block
1555). The CPM may then establish a call with a healthcare provider for the patient (Block
1556).
[0117] If the answer at Block
1554 is "No", the CPM sets a flag (
i.e., a reminder) to send the information provided by the patient regarding changes in
or presence of behavioral factors or other conditions that are not clearly related
to supra-therapeutic or sub-therapeutic conditions to a healthcare provider according
to a regular data transmission schedule (Block
1557). Operations are then returned to Block
1600 (Fig. 15).
[0118] Referring back to
Fig. 15, the CPM prompts the patient as to whether the patient is experiencing any sub-therapeutic
symptoms, signs or conditions (Block
1600). If the answer is "Yes", the CPM initiates a procedure for assessing the severity
of sub-therapeutic conditions (Block
1650).
[0119] Referring to
Fig. 19, a procedure for assessing the severity of sub-therapeutic conditions experienced
by a patient (Block
1650) is illustrated. The CPM prompts the patient to indicate supra-therapeutic signs,
conditions or symptoms that the patient is either experiencing for the first time,
or that have worsened (Block
1651). As is known to those of skill in the art, sub-therapeutic conditions related to
anticoagulation therapy include non-hemorrhagic signs, symptoms or conditions ("data"),
such as fever, vomiting, diarrhea, and the like. A check list is preferably provided
via a user interface that allows a patient to indicate sub-therapeutic data.
[0120] The CPM then determines, based on the provided sub-therapeutic symptom information,
whether the patient is at arterial risk (
i.e., at risk of arterial clot) (Block
1652). If the answer is "Yes", the CPM prompts the patient to indicate whether he/she
is experiencing new signs, symptoms or conditions, such as muscle weakness, slurred
speech, chest pains, and blindness or other vision problems (Block
1653). The CPM then determines, based on the provided information about new signs, symptoms
or conditions (data), whether the patient is also at risk for venous conditions (Block
1654). That is, the CPM determines whether the patient's symptoms or signs may be indicative
of a heart attack or stroke. If the answer is "Yes", the CPM prompts the patient to
indicate whether he/she is experiencing new venous signs or symptoms such as swollen
or hot arms and/or legs, chest pain, and shortness of breath (Block
1655).
[0121] The CPM then determines whether the patient's health data (venous and/or arterial)
require immediate medical attention (Block
1656). If the answer is "Yes", the CPM prompts the patient to call a healthcare provider
or to call for other emergency medical attention (Block
1657). A CPM may be configured to automatically establish voice communications with a
healthcare provider or emergency medical service for the patient. The existence of
serious arterial signs, symptoms or conditions may cause the CPM to inhibit warfarin
(and other medication) dosage recommendations until the data have been reviewed by
a healthcare provider.
[0122] If at Block
1656 the CPM determines that the patient's data are such that they do not require immediate
medical attention, the CPM then determines whether the data should be reviewed as
soon as the CPM entry session is complete (CPM has acquired all data) but before medication
is actually recommended, or whether the entry can be completed with medication recommended-but
with the contents of the entry to be logged and screened immediately following the
interactive CPM session (Block
1658).
[0123] If at Block
1658 the answer is "No", the CPM prompts the patient to determine whether the patient
wishes to talk with a healthcare provider about any identified or questionable signs,
symptoms or conditions (Block
1659). If the answer is "No", operations are returned to Block
1700 (
Fig. 15). If the answer at Block
1659 is "Yes", the CPM sets a flag to transmit the symptom information to a healthcare
provider, either now or at a future time (Block
1660). Operations are then returned to Block
1700 (Fig. 15).
[0124] Similarly, if the CPM determines at Block
1658 that the patient's conditions is not serious enough to require immediate medical
attention (i.e., the answer is "Yes"), the CPM sets a flag to transmit the symptom
information to a healthcare provider, either now or at a future time (Block
1660). Operations are then returned to Block
1700 (Fig. 15).
[0125] Referring back to
Fig. 15, the CPM assesses the need for the patient to self-perform PT testing at the present
time (Block
1700). With respect to anticoagulation therapy, a CPM typically will conclude that testing
should be performed if a patient has signs or symptoms of bleeding or clotting, or
changes in diet or other medications, illness, vomiting, diarrhea, or if the minimum
interval between tests has been exceeded. If the CPM determines that testing should
be performed, the CPM prompts the patient to perform the PT test and enter the results
in the CPM (Block
1750).
[0126] If the CPM determines that testing need not be performed, the CPM assesses the need
to establish a call with a healthcare provider at the present time (Block
1800). With respect to anticoagulation therapy, a CPM typically will conclude that a call
should be placed to a healthcare provider if a patient has bleeding signs or symptoms,
clotting signs or symptoms, changes in diet, vitamins or other medications, as well
as if the patient shows signs of illness, or has experienced vomiting and/or diarrhea.
If the CPM determines that a call should be placed, the CPM is configured to initiate
the call and establish voice communications and/or exchange data with the healthcare
provider via a communications network (Block
1850).
[0127] If the answer at Block
1800 is "No", the CPM assesses the need to adjust the patient's medication dosage (e.g.,
warfarin for anticoagulation therapy) (Block
1900). If the CPM determines that a patient's medication dosage should be adjusted, an
algorithm stored within the CPM is used to modify the medication dosage (Block
1950). The patient is notified of the medication dosage adjustment and is prompted to
administer the medication under the modified dosage (Block
1951).
[0128] The CPM then determines whether the patient's self-testing (
e.g., PT test) schedule should be adjusted based on available patient data or prior self-test
results (Block
2000). If the answer is "Yes", the patient's self-testing schedule is adjusted (Block
2050). Operations then return to Block
2100). If the answer at Block
2000 is "No", a determination is made whether a routine data transfer is scheduled (Block
2075). If the answer is "Yes", patient information is transmitted to a PAC server according
to schedule (Block
2100) as described above.
[0129] As is well known to those having skill in the art, a warfarin adjusting algorithm
relies on a target range for PT test results specified by a healthcare provider. At
the start of therapy, the desired PT test target range and patient's current weekly
and daily warfarin dosage levels are input, along with parameters that specify how
changes in warfarin doses are to be calculated. In the absence of serious symptom
reports, deviations in PT test results from the patient's specified target range are
corrected by a change in warfarin doses, utilizing physician-prescribed adjustment
parameters. Small deviations from the target PT range in previously stable patients
are corrected by transient or bolus dosage adjustments. Depending upon the magnitude
of the total amount of warfarin that must be added or subtracted from the weekly does,
either one- or two-day medication alterations are made. Somewhat larger deviations
from the target PT range that are unaccompanied by dangerous symptom reports are corrected
by the algorithm using a combination of an immediate change (positive or negative
bolus) and a permanent change in the weekly basal dose.
[0130] Changed weekly doses are spread across days according to a dosing schedule that may
result in the different doses being taken on even and odd days of the week. This is
desirable because patients cannot be expected to have an indefinite number of different
warfarin formulations (pill strengths) available, and it is possible because the half-life
of the major ingredient in Warfarin that affects PT is 48 to 72 hours. A CPM transparently
calculates dosage changes and divides the total weekly basal dose into a recommended
daily dose informed by immediately available medications. Warfarin pills may be scored
and, thus, may be cut in half if necessary. If new dosing requirements cannot be met
with an available supply of warfarin, the CPM instructs the patient to transmit a
request for another formulation of warfarin to be prescribed.
[0131] Computer code within a CPM may be configured to prompt a patient to place the device
in a dedicated modem cradle and initiate an IP link on both a scheduled and contingent
basis. A CPM can utilize secure socket layer (SSL) internet protocols for two-way
communication with a data processing system of a healthcare provider or other third
party. A CPM may be uniquely identified during the communications session. Patient
home-collected data are automatically uploaded and screened, and any newly available
self-monitoring or prescriptive parameters are automatically downloaded to the CPM
during the session. Both programmed and personalized messages can also be sent to
a patient to enhance compliance with the treatment or self-care regimen.
[0132] A CPM according to the present invention may be utilized within a system utilizing
a PAC server as described above. PAC server features that support remote management
of insulin therapy are well suited for anticoagulation therapy with warfarin, as well
as for a wide range of disease therapies. The PAC specification supports automated
voice message delivery that can be used to prompt patients to make appointments, return
calls or connect their CPM with a PAC server to obtain an updated warfarin management
prescription.
[0133] Patient data uploaded to a PAC server (Block
2100,
Fig. 15) can be screened in real-time for serious data (signs, symptoms or conditions) and
individualized deviations from specified physiologic levels. Serious data (signs,
symptoms or conditions), when detected, can contingently trigger paging of appropriate
medical personnel on an as needed basis. Patient problems can be hierarchically prioritized
by severity, and can contingently trigger software-initiated alarms for immediate
review by healthcare professionals. Problems such as failure to transfer data on schedule
and poor compliance with taking or recording prescribed warfarin doses can also be
identified. In the absence of problems a PAC server can also schedule semi-automated
periodic routine case reviews that document patient progress and can provide supportive
feedback delivered using email.
[0134] The foregoing is illustrative of the present invention and is not to be construed
as limiting thereof. Although a few exemplary embodiments of this invention have been
described, those skilled in the art will readily appreciate that many modifications
are possible in the exemplary embodiments without materially departing from the novel
teachings and advantages of this invention. Accordingly, all such modifications are
intended to be included within the scope of this invention as defined in the claims
. Therefore, it is to be understood that the foregoing is illustrative of the present
invention and is not to be construed as limited to the specific embodiments disclosed,
and that modifications to the disclosed embodiments, as well as other embodiments,
are intended to be included within the scope of the appended claims. The invention
is defined by the following claims, with equivalents of the claims to be included
therein.
1. A method for monitoring anticoagulation therapy of a patient, wherein the anticoagulation
therapy includes a patient-administered medication regimen selected from the group
consisting of warfarin and vitamin K antagonists, heparin and glucosaminoglycans,
and direct thrombin inhibitors, and a patient-administered regimen for a coagulation
test that monitors efficacy of the medication regimen, wherein the coagulation test
is selected from the group consisting of prothrombin time (PT) test, partial thromboplastin
time (PTT) test, activated clotting time (ACT) test, heparin assays, ecarin clotting
time (ECT) test, and thrombin clotting time test, wherein a portable apparatus is
configured to receive and analyse information regarding patient compliance with the
patient-administered medication and coagulation test regimens, and wherein the apparatus
is configured to modify the patient-administered medication and coagulation test regimens,
the method comprising the following steps performed by the portable apparatus:
receiving data from a patient, wherein the patient data includes at least one of physiological
data, pathophysiological data, biological data, psychological data, neuropsychological
data, and behavioural data;
assessing severity of the received patient data;
prompting the patient to perform a patient-administered coagulation test if the received
patient data are assessed to be above a threshold severity level;
receiving coagulation test results from the patient-administered test; and
communicating the received coagulation test results from the patient-administered
test to a healthcare provider via a communications network.
2. The method according to Claim 1 further comprising the steps of:
assessing severity of the received coagulation test results from the patient-administered
coagulation test;
modifying the patient-administered medication regimen if the received coagulation
test results from the patient-administered coagulation test are assessed to be above
a threshold severity level; and
communicating the modified patient-administered medication regimen to the patient.
3. The method according to Claim 2 further comprising the step of communicating the modified
patient-administered medication regimen to a healthcare provider via a communications
network.
4. The method according to Claim 2 further comprising the step of communicating the modified
patient-administered medication regimen to a remotely located data processing system
via a communications network.
5. The method according to Claim 1 further comprising the step of receiving from the
patient information about patient compliance with the patient-administered medication
and coagulation test regimens during a preceding time period.
6. The method according to Claim 1 further comprising the step of automatically communicating
the received patient data to a healthcare provider via a communications network if
patient data are assessed to be above a threshold severity level.
7. The method according to Claim 6 wherein the step of automatically communicating the
received patient data to a healthcare provider comprises paging the healthcare provider.
8. The method according to Claim 4 further comprising the step of communicating information
regarding medication dosage to the patient in response to determining, that the patient
did not comply with the medication regimen in the preceding time period.
9. The method according to Claim 1 wherein the received patient data comprises at least
one of information about hemorrhagic symptoms experienced by the patient and information
about non-hemorrhagic symptoms experienced by the patient.
10. A system for monitoring anticoagulation therapy of a patient, wherein the anticoagulation
therapy includes a patient-administered medication regimen selected from the group
consisting of warfarin and vitamin K antagonists, heparin and glucosaminoglycans,
and direct thrombin inhibitors, and a patient-administered regimen for a coagulation
test that monitors efficacy of the medication regimen, wherein the coagulation test
is selected from the group consisting of prothrombin time (PT) test, partial thromboplastin
time (PTT) test, activated clotting time (ACT) test, heparin assays, ecarin clotting
time (ECT) test, and thrombin clotting time test, wherein the system comprises:
a patient apparatus, comprising:
a processor;
a user interface in communication with the processor;
computer code executable by the processor that receives and stores data from a patient,
wherein the patient data includes at least one of physiological data, pathophysiological
data, biological data, psychological data, neuropsychological data, and behavioural
data;
computer code executable by the processor that assesses severity of the received patient
data;
computer code executable by the processor that prompts the patient via the user interface
to perform a patient-administered coagulation test if the received patient data are
assessed to be above a threshold severity level;
computer code executable by the processor that receives and stores coagulation test
results from the patient-administered coagulation test; and
computer code executable by the processor that communicates the received coagulation
test results from the patient-administered coagulation test to a healthcare provider
via a communications network.
11. The system according to claim 10, further comprising:
a remotely located data processing system configured to communicate with and receive
data from the patient apparatus, the remotely located data processing system comprising:
computer code that obtains patient data from the patient apparatus;
computer code that analyses the obtained patient data to identify medical conditions
of a patient;
computer code that displays identified patient medical conditions for a patient in
selectable, prioritised order according to medical severity via a remotely located
client in communication with the central data processing system; and
computer code that displays treatment options for treating a selected medical condition
for a patient.
12. The system according to Claim 10 wherein the patient apparatus further comprises:
computer code executable by the processor that assesses severity of the received coagulation
test results from the patient-administered coagulation test;
computer code executable by the processor that modifies the patient-administered medication
regimen if the received coagulation test results from the patient-administered coagulation
test are assessed to be above a threshold severity level; and
computer code executable by the processor that communicates the modified patient-administered
medication regimen to the patient.
13. The system according to Claim 11 further comprises computer code that communicates
treatment information from the remotely located data processing system to the patient
apparatus.
14. The system according to Claim 13 wherein the computer code that communicates treatment
information from the remotely located data processing system to the patient apparatus
comprises computer code that transmits treatment information via wireless, satellite,
telephone, e-mail, AVM or facsimile transmission.
15. The system according to Claim 13 wherein the computer code that communicates treatment
information from the remotely located data processing system to the patient apparatus
comprises computer code that modifies the medication algorithm within the patient
apparatus.
16. The system according to Claim 11 wherein the computer code that obtains patient data
from the patient apparatus further comprises:
computer code that analyses data transmitted from the patient apparatus substantially
simultaneously with the transmission thereof to remotely located data processing system
to identify emergency medical conditions requiring immediate medical attention; and
computer code that automatically communicates treatment information to the patient
apparatus for an identified emergency medical condition.
17. The system according to Claim 11 wherein the remotely located data processing systems
further comprises:
computer code that monitors patient usage of medication; and
computer code that orders medication for a patient from a supplier of medication.
18. The system according to Claim 11 wherein the computer code that displays identified
patient medical conditions comprises computer code that displays selected ones of
the identified patient medical conditions.
19. The system according to Claim 10 wherein the patient apparatus further comprises computer
code that receives information via the user interface about patient compliance with
the patient-administered medication regimen and the patient-administered coagulation
test regimen during a preceding time period.
20. The system according to Claim 10 wherein the patient apparatus further comprise computer
code that communicates information regarding medication dosage to a patient via the
user interface in response to determining that a patient did not comply with the patient-administered
medication regimen in a preceding time period.
21. The system according to Claim 12' further comprising computer code executable by the
processor that communicates the modified patient-administered medication regimen to
a healthcare provider via a communications network.
22. The system according to Claim 12 further comprising computer code executable by the
processor that communicates the modified patient-administered medication regimen to
a remotely located data processing system via a communications network.
23. The system according to Claim 10 further comprising computer code executable by the
processor that receives and stores information from a patient about patient compliance
with the patient-administered medication and coagulation test regimens during a preceding
time period.
24. The system according to Claim 10 further comprising computer code executable by the
processor that automatically communicates the received patient data to a healthcare
provider via a communications network if patient data are,assessed to be above a threshold
severity level.
25. The system according to Claim 24 wherein the computer code that automatically communicates
the received patient data to a healthcare provider comprises computer code that sends
a paging signal to a healthcare provider.
26. A method for monitoring disease therapy of a patient, wherein the disease is selected
from the group consisting of asthma, cancer chemotherapy, depression, high blood pressure,
seizure disorders, and thrombosis, wherein the disease therapy includes a patient-administered
medication regimen and a patient-administered regimen for a test that monitors efficacy
of the medication regimen, wherein a portable apparatus is configured to receive and
analyse information regarding patient compliance with the patient-administered medication
and test regimens, and wherein the portable apparatus is configured to modify the
patient-administered medication and test regimens, the method comprising the following
steps performed by the portable apparatus:
receiving data from a patient, wherein the patient data includes at least one of physiological
data, pathophysiological data, biological data, psychological data, neuropsychological
data, and behavioural data;
assessing severity of the received patient data;
prompting the patient to perform a patient-administered test if the received patient
data are assessed to be above a threshold severity level;
receiving test results from the patient-administered test; and
communicating the received test results from the patient-administered test to a healthcare
provider via a communications network.
27. The method according to Claim 26 further comprising the steps of:
assessing severity of the received test results from the patient-administered test;
modifying the patient-administered medication regimen if the received test results
from the patient-administered test are assessed to be above a threshold severity level;
and
communicating the modified patient-administered medication regimen to the patient.
28. The method according to Claim 27 further comprising the step of communicating the
modified patient-administered medication regimen to a healthcare provider via a communications
network.
29. The method according to Claim 27 further comprising the step of communicating the
modified patient-administered medication regimen to a remotely located data processing
system via a communications network.
30. The method according to Claim 26 further comprising the step of receiving from the
patient information about patient compliance with the patient-administered medication
and test regimens during a preceding time period.
31. The method according to Claim 26 further comprising the step of automatically communicating
the received patient data to a healthcare provider via a communications network if
patient data are assessed to be above a threshold severity level.
32. The method according to Claim 29 further comprising the step of communicating information
regarding medication dosage to the patient in response to determining that the patient
did not comply with the medication regimen in the preceding time period.
33. The method according to Claim 26 wherein the received patient data further comprises
at least one of information about a supra-therapeutic symptom experienced by the patient
and information about a sub-therapeutic symptom experienced by the patient.
34. An apparatus for monitoring disease therapy of a patient, wherein the disease is selected
from the group consisting of asthma, cancer chemotherapy, depression, high blood pressure,
seizure disorders, and thrombosis, wherein the disease therapy includes a patient-administered
medication regimen and a patient-administered regimen for a test that monitors efficacy
of the medication regimen, the apparatus comprising:
a processor;
a user interface in communication with the processor;
computer code executable by the processor that receives and stores data from a patient,
wherein the patient data includes at least one of physiological data, pathophysiological
data, biological data, psychological data, neuropsychological data, and behavioural
data;
computer code executable by the processor that assesses severity of the received patient
data;
computer code executable by the processor that prompts the patient via the user interface
to perform a patient-administered test if the received patient data are assessed to
be above a threshold severity level;
computer code executable by the processor that receives and stores test results from
the patient-administered test; and
computer code executable by the processor that communicates the received test results
from the patient-administered test to a healthcare provider via a communications network.
35. The apparatus according to Claim 34 further comprising:
computer code executable by the processor that assesses severity of the received test
results from the patient-administered test;
computer code executable by the processor that modifies the patient-administered medication,
regimen if the received test results from the patient-administered test are assessed
to be above a threshold severity level; and
computer code executable by the processor that communicates the modified patient-administered
medication regimen to the patient.
36. The apparatus according to Claim 35 further comprising computer code executable by
the processor that communicates the modified patient-administered medication regimen
to a healthcare provider via a communications network.
37. The apparatus according to Claim 35 further comprising computer code executable by
the processor that communicates the modified patient-administered medication regimen
to a remotely located data processing system via a communications network.
38. The apparatus according to Claim 34 further comprising computer code executable by
the processor that receives and stores information provided by the patient about patient
compliance with the patient-administered medication and test regimens during preceding
time period.
39. The apparatus according to Claim 34 further comprising computer code executable by
the processor that automatically communicates the received patient data to a healthcare
provider via a communications network if patient data are assessed to be above a threshold
severity level.
40. The apparatus according to Claim 37 further comprising computer code executable by
the processor that communicates information regarding medication dosage to the patient
in response to determining that the patient did not comply with the medication regimen
in the preceding time period.
41. A computer program product directly loadable into the internal memory of a digital
computer comprising software code portions for performing the steps of Claim 1, and
any claim dependent therefrom, when said product is run on a computer.
42. A computer program product directly loadable into the internal memory of a digital
computer comprising software code portions for performing the steps of Claim 26, and
any claim dependent therefrom, when said product is run on a computer.
1. Verfahren zum Überwachen der Antikoagulationstherapie eines Patienten, wobei die Antikoagulationstherapie
einen vom Patienten einzuhaltenden Medikamentenplan, ausgewählt aus der Gruppe bestehend
aus Warfarin und Vitamin K Antagonisten, Heparin und Glukosaminoglycanen und direkten
Thrombininhibitoren, und einen vom Patienten einzuhaltenden Koagulationstestplan beinhaltet,
der die Wirksamkeit des Medikamentenplans überwacht, wobei der Koagulationstest ausgewählt
ist aus der Gruppe bestehend aus PT-(Prothrombinzeit)-Test, PTT-(partielle Thromboplastinzeit)-Test,
ACT-(aktivierte Gerinnungszeit)-Test, Heparin-Assays, ECT-(Ecaringerinnungszeit)-Test
und Thrombingerinnungszeit-Test, wobei eine tragbare Vorrichtung so konfiguriert ist,
dass sie Informationen über Patienten-Compliance mit den vom Patienten einzuhaltenden
Medikamenten- und Koagulationstestplänen empfängt und analysiert, und wobei die Vorrichtung
so konfiguriert ist, dass sie die vom Patienten einzuhaltenden Medikamenten- und Koagulationstestpläne
verändert, wobei das Verfahren die folgenden von der tragbaren Vorrichtung ausgeführten
Schritte beinhaltet:
Empfangen von Daten von einem Patienten, wobei die Patientendaten physiologische Daten,
pathophysiologische Daten, biologische Daten, psychologische Daten, neuropsychologische
Daten und/oder Verhaltensdaten beinhalten;
Beurteilen der Ernsthaftigkeit der empfangenen Patientendaten;
Auffordern des Patienten, einen vom Patienten durchführenden Koagulationstest durchzuführen,
wenn die erhaltenen Patientendaten als über einem Ernsthaftigkeitsschwellenwert liegend
beurteilt werden;
Empfangen von Koagulationstestergebnissen des vom Patienten durchzuführenden Tests;
und
Übermitteln der empfangenen Koagulationstestergebnisse des vom Patienten durchzuführenden
Tests über ein Kommunikationsnetz an einen Gesundheitsdienstleister.
2. Verfahren nach Anspruch 1, das ferner die folgenden Schritte beinhaltet:
Beurteilen der Ernsthaftigkeit der empfangenen Koagulationstestergebnisse des vom
Patienten durchzuführenden Koagulationstests;
Verändern des vom Patienten einzuhaltenden Medikamentenplans, wenn die empfangenen
Koagulationstestergebnisse des vom Patienten durchzuführenden Koagulationstests als
über einem Ernsthaftigkeitsschwellenwert liegend beurteilt werden; und
Übermitteln des veränderten vom Patienten einzuhaltenden Medikamentenplans an den
Patienten.
3. Verfahren nach Anspruch 2, das ferner den Schritt des Übermittelns des veränderten
vom Patienten einzuhaltenden Medikamentenplans über ein Kommunikationsnetz an einen
Gesundheitsdienstleister beinhaltet.
4. Verfahren nach Anspruch 2, das ferner den Schritt des Übermittelns des veränderten
vom Patienten einzuhaltenden Medikamentenplans über ein Kommunikationsnetz an ein
ortsfern befindliches Datenverarbeitungssystem beinhaltet.
5. Verfahren nach Anspruch 1, das ferner den Schritt des Empfangens von Informationen
von dem Patienten über Patienten-Compliance mit den vom Patienten einzuhaltenden Medikamenten-
und Koagulationstestplänen während einer vorangegangenen Zeitperiode beinhaltet.
6. Verfahren nach Anspruch 1, das ferner den Schritt des automatischen Übermittelns der
empfangenen Patientendaten über ein Kommunikationsnetz an einen Gesundheitsdienstleister
beinhaltet, wenn Patientendaten als über einem Ernsthaftigkeitsschwellenwert liegend
beurteilt werden.
7. Verfahren nach Anspruch 6, wobei der Schritt des automatischen Übermittelns der empfangenen
Patientendaten an einen Gesundheitsdienstleister einen Funkruf an den Gesundheitsdienstleister
beinhaltet.
8. Verfahren nach Anspruch 4, das ferner den Schritt des Übermittelns von Informationen
über Medikamentendosierung an den Patienten als Reaktion auf die Feststellung beinhaltet,
dass der Patient den Medikamentenplan in der vorangegangenen Zeitperiode nicht eingehalten
hat.
9. Verfahren nach Anspruch 1, wobei die empfangenen Patientendaten Informationen über
vom Patienten erfahrene hämorrhagische Symptome und/oder Informationen über vom Patienten
erfahrene nicht-hämorrhagische Symptome beinhalten.
10. System zum Überwachen der Antikoagulationstherapie eines Patienten, wobei die Antikoagulationstherapie
einen vom Patienten einzuhaltenden Medikamentenplan, ausgewählt aus der Gruppe bestehend
aus Warfarin und Vitamin K Antagonisten, Heparin und Glukosaminoglycanen und direkten
Thrombininhibitoren, und einen vom Patienten einzuhaltenden Koagulationstestplan beinhaltet,
der die Wirksamkeit des Medikamentenplans überwacht, wobei der Koagulationstest ausgewählt
ist aus der Gruppe bestehend aus PT-(Prothrombinzeit)-Test, PTT-(partielle Thromboplastinzeit)-Test,
ACT-(aktivierte Gerinnungszeit)-Test, Heparin-Assays, ECT-(Ecaringerinnungszeit)-Test
und Thrombingerinnungszeit-Test, wobei das System Folgendes umfasst:
eine Patientenvorrichtung, die Folgendes umfasst:
einen Prozessor;
eine Benutzeroberfläche in Verbindung mit dem Prozessor;
Computercode, der vom Prozessor ausgeführt werden kann, der Daten von einem Patienten
empfängt und speichert, wobei die Patientendaten physiologische Daten, pathophysiologische
Daten, biologische Daten, psychologische Daten, neuropsychologische Daten und/oder
Verhaltensdaten beinhalten;
Computercode, der vom Prozessor ausgeführt werden kann, der die Ernsthaftigkeit der
empfangenen Patientendaten beurteilt;
Computercode, der vom Prozessor ausgeführt werden kann, der den Patienten über die
Benutzeroberfläche auffordert, einen vom Patienten durchzuführenden Koagulationstest
durchzuführen, wenn die empfangenen Patientendaten als über einem Ernsthaftigkeitsschwellenwert
liegend beurteilt werden;
Computercode, der vom Prozessor ausgeführt werden kann, der Koagulationstestergebnisse
des vom Patienten durchzuführenden Koagulationstests empfängt und speichert; und
Computercode, der vom Prozessor ausgeführt werden kann, der die empfangenen Koagulationstestergebnisse
des vom Patienten durchzuführenden Koagulationstests über ein Kommunikationsnetz an
einen Gesundheitsdienstleister übermittelt.
11. System nach Anspruch 10, das ferner Folgendes umfasst:
ein ortsfern befindliches Datenverarbeitungssystem, das so konfiguriert ist, dass
es mit der Patientenvorrichtung kommuniziert und Daten von ihr empfängt, wobei das
ortsfern befindliche Datenverarbeitungssystem Folgendes umfasst:
Computercode, der Patientendaten von der Patientenvorrichtung einholt;
Computercode, der die eingeholten Patientendaten analysiert, um medizinische Zustände
eines Patienten zu identifizieren;
Computercode, der identifizierte medizinische Patientenzustände für einen Patienten
in einer wählbaren Prioritätsfolge nach medizinischer Ernsthaftigkeit über einen ortsfern
befindlichen Client anzeigt, der mit dem zentralen Datenverarbeitungssystem in Kommunikation
ist; und
Computercode, der Behandlungsoptionen zum Behandeln eines gewählten medizinischen
Zustands für einen Patienten anzeigt.
12. System nach Anspruch 10, wobei die Patientenvorrichtung ferner Folgendes umfasst:
Computercode, der vom Prozessor ausgeführt werden kann, der die Ernsthaftigkeit der
empfangenen Koagulationstestergebnisse des vom Patienten durchzuführenden Koagulationstests
beurteilt;
Computercode, der vom Prozessor ausgeführt werden kann, der den vom Patienten einzuhaltenden
Medikamentenplan verändert, wenn die empfangenen Koagulationstestergebnisse des vom
Patienten durchzuführenden Koagulationstests als über einem Ernsthaftigkeitsschwellenwert
liegend beurteilt werden; und
Computercode, der vom Prozessor ausgeführt werden kann, der dem Patienten den veränderten
vom Patienten einzuhaltenden Medikamentenplan übermittelt.
13. System nach Anspruch 11, das ferner Computercode umfasst, der Behandlungsinformationen
von dem ortsfern befindlichen Datenverarbeitungssystem an die Patientenvorrichtung
übermittelt.
14. System nach Anspruch 13, wobei der Computercode, der Behandlungsinformationen von
dem ortsfern befindlichen Datenverarbeitungssystem an die Patientenvorrichtung übermittelt,
Computercode umfasst, der Behandlungsinformationen per Funk, Satellit, Telefon, Email,
AVM oder Telefax überträgt.
15. System nach Anspruch 13, wobei der Computercode, der Behandlungsinformationen von
dem ortsfern befindlichen Datenverarbeitungssystem an die Patientenvorrichtung übermittelt,
Computercode umfasst, der den Medikationsalgorithmus in der Patientenvorrichtung verändert.
16. System nach Anspruch 11, wobei der Computercode, der Patientendaten von der Patientenvorrichtung
einholt, ferner Folgendes umfasst:
Computercode, der von der Patientenvorrichtung übertragene Daten im Wesentlichen gleichzeitig
mit deren Übertragung zu dem ortsfern befindlichen Datenverarbeitungssystem analysiert,
um medizinische Notfallzustände zu identifizieren, die sofortiger medizinischer Aufmerksamkeit
bedürfen; und
Computercode, der automatisch Behandlungsinformationen für einen identifizierten medizinischen
Notfallzustand an die Patientenvorrichtung übermittelt.
17. System nach Anspruch 11, wobei die ortsfern befindlichen Datenverarbeitungssysteme
ferner Folgendes umfassen:
Computercode, der den Patientengebrauch der Medikamente überwacht; und
Computercode, der Medikamente für einen Patienten bei einem Medikamentenvertrieb bestellt.
18. System nach Anspruch 11, wobei der Computercode, der identifizierte medizinische Patientenzustände
anzeigt, Computercode umfasst, der ausgewählte der identifizierten medizinischen Patientenzustände
anzeigt.
19. System nach Anspruch 10, wobei die Patientenvorrichtung ferner Computercode umfasst,
der Informationen über die Benutzeroberfläche über Patienten-Compliance mit dem vom
Patienten einzuhaltenden Medikamentenplan und dem vom Patienten einzuhaltenden Koagulationstestplan
während einer vorangegangenen Zeitperiode empfängt.
20. System nach Anspruch 10, wobei die Patientenvorrichtung ferner Computercode umfasst,
der Informationen über die Medikamentendosierung über die Benutzeroberfläche an einen
Patienten als Reaktion auf die Feststellung übermittelt, dass ein Patient den vom
Patienten einzuhaltenden Medikamentenplan in einer vorangegangenen Zeitperiode nicht
eingehalten hat.
21. System nach Anspruch 12, das ferner Computercode umfasst, der vom Prozessor ausgeführt
werden kann, der den veränderten, vom Patienten einzuhaltenden Medikamentenplan über
ein Kommunikationsnetz an einen Gesundheitsdienstleister übermittelt.
22. System nach Anspruch 12, das ferner Computercode umfasst, der vom Prozessor ausgeführt
werden kann, der den veränderten, vom Patienten einzuhaltenden Medikamentenplan über
ein Computernetz an ein ortsfern befindliches Datenverarbeitungssystem übermittelt.
23. System nach Anspruch 10, das ferner Computercode umfasst, der vom Prozessor ausgeführt
werden kann, der Informationen von einem Patienten über Patienten-Compliance mit den
vom Patienten einzuhaltenden Medikamenten- und Koagulationstestplänen während einer
vorangegangenen Zeitperiode empfängt und speichert.
24. System nach Anspruch 10, das ferner Computercode umfasst, der vom Prozessor ausgeführt
werden kann, der die empfangenen Patientendaten automatisch über ein Kommunikationsnetz
an einen Gesundheitsdienstleister übermittelt, wenn Patientendaten als über einem
Ernsthaftigkeitsschwellenwert liegend beurteilt werden.
25. System nach Anspruch 24, wobei der Computercode, der die empfangenen Patientendaten
automatisch an einen Gesundheitsdienstleister übermittelt, Computercode umfasst, der
ein Funkrufsignal an einen Gesundheitsdienstleister sendet.
26. Verfahren zur Überwachung einer Krankheitstherapie eines Patienten, wobei die Krankheit
ausgewählt ist aus der Gruppe bestehend aus Asthma, Krebschemotherapie, Depression,
Bluthochdruck, Anfallerkrankungen und Thrombose, wobei die Krankheitstherapie einen
vom Patienten einzuhaltenden Medikamentenplan und einen vom Patienten einzuhaltenden
Testplan beinhaltet, der die Wirksamkeit des Medikamentenplans überwacht, wobei eine
tragbare Vorrichtung zum Empfangen und Analysieren von Informationen über Patienten-Compliance
mit den vom Patienten einzuhaltenden Medikamenten- und Testplänen konfiguriert ist
und wobei die tragbare Vorrichtung zum Verändern der vom Patienten einzuhaltenden
Medikamenten- und Testpläne konfiguriert ist, wobei das Verfahren die folgenden von
der tragbaren Vorrichtung ausgeführten Schritte beinhaltet:
Empfangen von Daten von einem Patienten, wobei die Patientendaten physiologische Daten,
pathophysiologische Daten, biologische Daten, psychologische Daten, neuropsychologische
Daten und/oder Verhaltensdaten beinhalten;
Beurteilen der Ernsthaftigkeit der empfangenen Patientendaten;
Auffordern des Patienten, einen vom Patienten durchzuführenden Test durchzuführen,
wenn die empfangenen Patientendaten als über einem Ernsthaftigkeitsschwellenwert liegend
beurteilt werden;
Empfangen von Testergebnissen des vom Patienten durchzuführenden Tests; und
Übermitteln der empfangenen Testergebnisse des vom Patienten durchzuführenden Tests
über ein Kommunikationsnetz an einen Gesundheitsdienstleister.
27. Verfahren nach Anspruch 26, das ferner die folgenden Schritte beinhaltet:
Beurteilen der Ernsthaftigkeit der empfangenen Testergebnisse des vom Patienten durchzuführenden
Tests;
Verändern des vom Patienten einzuhaltenden Medikamentenplans, wenn die empfangenen
Testergebnisse des vom Patienten durchzführenden Tests als über einem Ernsthaftigkeitsschwellenwert
liegend beurteilt werden; und
Übermitteln des veränderten, vom Patienten einzuhaltenden Medikamentenplans an den
Patienten.
28. Verfahren nach Anspruch 27, das ferner den Schritt des Übermittelns des veränderten,
vom Patienten einzuhaltenden Medikamentenplans über ein Kommunikationsnetz an einen
Gesundheitsdienstleister beinhaltet.
29. Verfahren nach Anspruch 27, das ferner den Schritt des Übermittelns des veränderten,
vom Patienten einzuhaltenden Medikamentenplans über ein Kommunikationsnetz an ein
ortsfern befindliches Datenverarbeitungssystem beinhaltet.
30. Verfahren nach Anspruch 26, das ferner den Schritt des Empfangens von Informationen
vom Patienten über die Patienten-Compliance mit den vom Patienten einzuhaltenden Medikamenten-
und Testplänen während einer vorangegangenen Zeitperiode beinhaltet.
31. Verfahren nach Anspruch 26, das ferner den Schritt des automatischen Übermittelns
der empfangenen Patientendaten über ein Kommunikationsnetz an einen Gesundheitsdienstleister
beinhaltet, wenn Patientendaten als über einem Ernsthaftigkeitsschwellenwert liegend
beurteilt werden.
32. Verfahren nach Anspruch 29, das ferner den Schritt des Übermittelns von Informationen
über Medikamentendosierung an den Patienten als Reaktion auf die Feststellung beinhaltet,
dass der Patient den Medikamentenplan in der vorangegangenen Zeitperiode nicht eingehalten
hat.
33. Verfahren nach Anspruch 26, wobei die empfangenen Patientendaten ferner Informationen
über ein vom Patienten erfahrenes supertherapeutisches Symptom und/oder Informationen
über ein vom Patienten erfahrenes subtherapeutisches Symptom beinhalten.
34. Vorrichtung zum Überwachen der Krankheitstherapie eines Patienten, wobei die Krankheit
ausgewählt ist aus der Gruppe bestehend aus Asthma, Krebschemotherapie, Depression,
Bluthochdruck, Anfallerkrankungen und Thrombose, wobei die Krankheitstherapie einen
vom Patienten einzuhaltenden Medikamentenplan und einen vom Patienten einzuhaltenden
Testplan beinhaltet, der die Wirksamkeit des Medikamentenplans überwacht, wobei die
Vorrichtung Folgendes umfasst:
einen Prozessor;
eine Benutzeroberfläche in Verbindung mit dem Prozessor;
Computercode, der vom Prozessor ausgeführt werden kann, der Daten von einem Patienten
empfängt und speichert, wobei die Patientendaten physiologische Daten, pathophysiologische
Daten, biologische Daten, psychologische Daten, neuropsychologische Daten und/oder
Verhaltensdaten beinhalten;
Computercode, der vom Prozessor ausgeführt werden kann, der die Ernsthaftigkeit der
empfangenen Patientendaten beurteilt;
Computercode, der vom Prozessor ausgeführt werden kann, der den Patienten über die
Benutzeroberfläche auffordert, einen vom Patienten durchzuführenden Test durchzuführen,
wenn die empfangenen Patientendaten als über einem Ernsthaftigkeitsschwellenwert liegend
beurteilt werden;
Computercode, der vom Prozessor ausgeführt werden kann, der Testergebnisse über den
vom Patienten durchzuführenden Test empfängt und speichert; und
Computercode, der vom Prozessor ausgeführt werden kann, der die empfangenen Testergebnisse
des vom Patienten durchzuführenden Tests über ein Kommunikationsnetz an einen Gesundheitsleister
übermittelt.
35. Vorrichtung nach Anspruch 34, die ferner Folgendes umfasst:
Computercode, der vom Prozessor ausgeführt werden kann, der die Ernsthaftigkeit der
empfangenen Testergebnisse des vom Patienten durchzuführenden Tests beurteilt;
Computercode, der vom Prozessor ausgeführt werden kann, der den vom Patienten einzuhaltenden
Medikamentenplan verändert, wenn die empfangenen Testergebnisse des vom Patienten
durchzuführenden Tests als über einem Ernsthaftigkeitsschwellenwert liegend beurteilt
werden; und
Computercode, der vom Prozessor ausgeführt werden kann, der den veränderten vom Patienten
einzuhaltenden Medikamentenplan an den Patienten übermittelt.
36. Vorrichtung nach Anspruch 35, die ferner Computercode umfasst, der vom Prozessor ausgeführt
werden kann, der den veränderten vom Patienten einzuhaltenden Medikamentenplan über
ein Kommunikationsnetz an einen Gesundheitsdienstleister übermittelt.
37. Vorrichtung nach Anspruch 35, die ferner Computercode umfasst, der vom Prozessor ausgeführt
werden kann, der den veränderten vom Patienten einzuhaltenden Medikamentenplan über
ein Kommunikationsnetz an ein ortsfern befindliches Datenverarbeitungssystem übermittelt.
38. Vorrichtung nach Anspruch 34, die ferner Computercode umfasst, der vom Prozessor ausgeführt
werden kann, der vom Patienten gegebene Informationen über Patienten-Compliance mit
den vom Patienten einzuhaltenden Medikamenten- und Testplänen während der vorangegangenen
Zeitperiode empfängt und speichert.
39. Vorrichtung nach Anspruch 34, die ferner Computercode umfasst, der vom Prozessor ausgeführt
werden kann, der die empfangenen Patientendaten automatisch über ein Kommunikationsnetz
an einen Gesundheitsdienstleister übermittelt, wenn Patientendaten als über einem
Ernsthaftigkeitsschwellenwert liegend beurteilt werden.
40. Vorrichtung nach Anspruch 37, die ferner Computercode umfasst, der vom Prozessor ausgeführt
werden kann, der Informationen über Medikamentendosierung an den Patienten als Reaktion
auf die Feststellung übermittelt, dass der Patient den Medikamentenplan in der vorangegangenen
Zeitperiode nicht eingehalten hat.
41. Computerprogrammprodukt, das direkt in den internen Speicher eines digitalen Computers
geladen werden kann, umfassend Softwarecode-Teile zum Ausführen der Schritte von Anspruch
1 und den davon abhängigen Ansprüchen, wenn das genannte Produkt auf einem Computer
abgearbeitet wird.
42. Computerprogrammprodukt, das direkt in den internen Speicher eines digitalen Computers
geladen werden kann, umfassend Softwarecode-Teile zum Ausführen der Schritte von Anspruch
26 und den davon abhängigen Ansprüchen, wenn das genannte Produkt auf einem Computer
abgearbeitet wird.
1. Procédé pour surveiller la thérapie anticoagulante d'un patient, cette thérapie anticoagulante
comprenant un régime de médicaments administré par le patient sélectionné parmi le
groupe comprenant la warfarine et les antagonistes de la vitamine K, l'héparine et
les glucosaminoglycanes, et les inhibiteurs directs de la thrombine, et un régime
administré par le patient pour un test de coagulation qui surveille l'efficacité du
régime de médicaments, ce test de coagulation étant sélectionné parmi le groupe comprenant
le test de Quick (PT), le test de temps de thromboplastine partielle (PTT), le test
de temps de coagulation activé (ACT), les dosages d'héparine, le test de temps de
coagulation à l'écarine (ECT), le test de temps de coagulation à la thrombine, dans
lequel un appareil portatif est configuré de façon à recevoir et à analyser des informations
concernant l'observance du patient des régimes de médicaments et de test de coagulation
administrés par le patient, et dans lequel l' appareil est configuré de façon à modifier
les régimes de médicaments et de test de coagulation administrés par le patient, ce
procédé comprenant les étapes suivantes exécutées par l'appareil portatif :
la réception de données provenant d'un patient, ces données du patient comprenant
au moins un des types de données suivants : données physiologiques, données pathophysiologiques,
données biologiques, données psychologiques, données neuropsychologiques, données
du comportement ;
l'évaluation de la sévérité des données du patient reçues ;
l'incitation du patient à exécuter un test de coagulation administré par le patient
si les données du patient reçues sont évaluées comme étant au-dessus d'un niveau seuil
de sévérité ;
la réception des résultats de test provenant du test administré par le patient ; et
la communication des résultats de test de coagulation reçus provenant du test administré
par le patient à un fournisseur de soins de santé via un réseau de communication.
2. Procédé selon la revendication 1, comprenant en outre les étapes consistant à :
évaluer la sévérité des résultats de test de coagulation reçus provenant du test de
coagulation administré par le patient ;
modifier le régime de médicaments administré par le patient si les résultats de test
de coagulation reçus provenant du test de coagulation administré par le patient sont
évalués comme étant au-dessus d'un niveau de seuil de sévérité ; et à
communiquer au patient le régime modifié de médicaments administré par le patient.
3. Procédé selon la revendication 2, comprenant en outre l'étape consistant à communiquer
le régime modifié de médicaments administré par le patient à un fournisseur de soins
de santé via un réseau de communication.
4. Procédé selon la revendication 2, comprenant en outre l'étape consistant à communiquer
le régime modifié de médicaments administré par le patient à un système de traitement
des données situé à distance via un réseau de communication.
5. Procédé selon la revendication 1, comprenant en outre l'étape consistant à recevoir
du patient des informations sur l'observance du patient des régimes de médicaments
et de test de coagulation administrés par le patient pendant une période de temps
précédente.
6. Procédé selon la revendication 1, comprenant en outre l'étape consistant à communiquer
automatiquement les données du patient reçues à un fournisseur de soins de santé via
un réseau de communication si les données du patient sont évaluées comme étant au-dessus
d'un niveau seuil de sévérité.
7. Procédé selon la revendication 6, dans lequel l'étape consistant à communiquer automatiquement
les données du patient reçues à un fournisseur de soins de santé comprend le téléavertissement
du fournisseur de soins de santé.
8. Procédé selon la revendication 4, comprenant en outre l'étape consistant à communiquer
au patient des informations concernant le dosage des médicaments en réponse à la détermination
que le patient n'a pas observé le régime de médicaments pendant la période de temps
précédente.
9. Procédé selon la revendication 1, dans lequel les données du patient reçues comprennent
au moins soit des informations sur les symptômes hémorragiques ressentis par le patient,
soit des informations sur les symptômes non hémorragiques ressentis par le patient.
10. Système pour surveiller la thérapie anticoagulante d'un patient, cette thérapie anticoagulante
comprenant un régime de médicaments administré par le patient sélectionné parmi le
groupe comprenant la warfarine et les antagonistes de la vitamine K, l'héparine et
les glucosaminoglycanes, et les inhibiteurs directs de la thrombine, et un régime
administré par le patient pour un test de coagulation qui surveille l'efficacité du
régime de médicaments, ce test de coagulation étant sélectionné parmi le groupe comprenant
le test de Quick (PT), le test de temps de thromboplastine partielle (PTT), le test
de temps de coagulation activé (ACT), les dosages d'héparine, le test de temps de
coagulation à l'écarine (ECT), le test de temps de coagulation à la thrombine, ce
système comprenant :
un appareil de patient, comprenant :
un processeur ;
une interface utilisateur en communication avec ce processeur ;
un code machine exécutable par le processeur, qui reçoit et stocke les données provenant
d'un patient, ces données du patient comprenant au moins un des types de données suivants
: données physiologiques, données pathophysiologiques, données biologiques, données
psychologiques, données neuropsychologiques, données du comportement ;
un code machine exécutable par le processeur qui évalue la sévérité des données du
patient reçues ;
un code machine exécutable par le processeur qui incite le patient, via l'interface
utilisateur, à exécuter un test de coagulation administré par le patient si les données
du patient reçues sont évaluées comme étant au-dessus d'un niveau seuil de sévérité
;
un code machine exécutable par le processeur, qui reçoit et stocke les résultats de
test de coagulation provenant du test de coagulation administré par le patient ; et
un code machine exécutable par le processeur qui communique les résultats de test
de coagulation reçus provenant du test de coagulation administré par le patient à
un fournisseur de soins de santé via un réseau de communication.
11. Système selon la revendication 10, comprenant en outre :
un système de traitement des données situé à distance configuré de façon à communiquer
avec l'appareil du patient et à recevoir des données de celui-ci, ce système de traitement
des données situé à distance comprenant :
un code machine qui obtient les données du patient à partir de l'appareil du patient
;
un code machine qui analyse les données du patient obtenues afin d'identifier des
troubles médicaux d'un patient ;
un code machine qui affiche des troubles médicaux du patient identifiés pour un patient
dans un ordre de priorité sélectionnable selon la sévérité médicale via un client
situé à distance en communication avec le système central de traitement des données
; et
un code machine qui affiche les options de traitement pour traiter un trouble médical
sélectionné pour un patient.
12. Système selon la revendication 10, dans lequel l'appareil du patient comprend en outre
:
un code machine exécutable par le processeur, qui évalue les résultats de test de
coagulation provenant de l'essai de coagulation administré par le patient ;
un code machine exécutable par le processeur qui modifie le régime de médicaments
administré par le patient si les résultats de test de coagulation reçus provenant
du test de coagulation administré par le patient sont évalués comme étant au-dessus
d'un niveau seuil de sévérité ; et
un code machine exécutable par le processeur qui communique au patient le régime modifié
de médicaments administré par le patient.
13. Système selon la revendication 11, comprenant en outre un code machine qui communique
à l'appareil du patient les informations de traitement provenant du système de traitement
des données situé à distance.
14. Système selon la revendication 13, dans lequel le code machine qui communique à l'appareil
du patient les informations de traitement provenant du système de traitement des données
situé à distance comprend un code machine qui transmet les informations de traitement
par transmission sans fil, par satellite, par téléphone, par courrier électronique,
par messagerie vocale automatisée ou par télécopie.
15. Système selon la revendication 13, dans lequel le code machine qui communique à l'appareil
du patient les informations de traitement provenant du système de traitement des données
situé à distance comprend un code machine qui modifie l'algorithme de médication à
l'intérieur de l'appareil du patient.
16. Système selon la revendication 11, dans lequel le code machine qui obtient les données
du patient à partir de l'appareil du patient comprend en outre ;
un code machine qui analyse les données transmises à partir de l'appareil du patient
essentiellement simultanément à la transmission de celles-ci au système de traitement
des données situé à distance afin d'identifier des troubles médicaux d'urgence nécessitant
des soins médicaux immédiats ; et
un code machine qui communique automatiquement les informations de traitement à l'appareil
du patient pour un trouble médical d'urgence identifié.
17. Système selon la revendication 11, dans lequel le système de traitement des données
situé à distance comprend en outre :
un code machine qui surveille l'emploi des médicaments par le patient ; et
un code machine qui commande des médicaments pour un patient auprès d'un fournisseur
de médicaments.
18. Système selon la revendication 11, dans lequel le code machine qui affiche les troubles
médicaux du patient identifiés comprend un code machine qui affiche des troubles sélectionnés
des troubles médicaux du patient identifiés.
19. Système selon la revendication 10, dans lequel l'appareil du patient comprend en outre
un code machine qui reçoit des informations via l'interface utilisateur à propos de
l'observance du patient du régime de médicaments administré par le patient et du régime
de test de coagulation administré par le patient pendant une période de temps précédente.
20. Système selon la revendication 10, dans lequel l'appareil du patient comprend en outre
un code machine qui communique des informations concernant le dosage des médicaments
à un patient via l'interface utilisateur en réponse à la détermination qu'un patient
n'a pas observé le régime de médicaments administré par le patient pendant une période
de temps précédente.
21. Système selon la revendication 12, comprenant en outre un code machine exécutable
par le processeur qui communique le régime modifié de médicaments administré par le
patient à un fournisseur de soins de santé via un réseau de communication.
22. Système selon la revendication 12, comprenant en outre un code machine exécutable
par le processeur qui communique le régime modifié de médicaments administré par le
patient à un système de traitement des données situé à distance via un réseau de communication.
23. Système selon la revendication 10, comprenant en outre un code machine exécutable
par le processeur qui reçoit et stocke des informations provenant d'un patient sur
l'observance du patient des régimes de médicaments et de test de coagulation administrés
par le patient pendant une période de temps précédente.
24. Système selon la revendication 10, comprenant un code machine exécutable par le processeur
qui communique automatiquement les données du patient reçues à un fournisseur de soins
de santé via un réseau de communication si les données du patient sont évaluées comme
étant au-dessus d'un niveau seuil de sévérité.
25. Système selon la revendication 24, dans lequel le code machine qui communique automatiquement
les données du patient reçues à un fournisseur de soins de santé comprend un code
machine qui envoie un signal de téléavertissement à un fournisseur de soins de santé.
26. Procédé pour surveiller le traitement de la maladie d'un patient, cette maladie étant
sélectionnée parmi le groupe comprenant l'asthme, la chimiothérapie anticancéreuse,
la dépression, l'hypertension artérielle, les troubles épileptiques et la thrombose,
le traitement de la maladie comprenant un régime de médicaments administré par le
patient et un régime administré par le patient pour un test qui surveille l'efficacité
du régime de médicaments, dans lequel un appareil portatif est configuré de façon
à recevoir et à analyser des informations concernant l'observance par le patient des
régimes de médicaments et de test administrés par le patient, et dans lequel l'appareil
portatif est configuré de façon à modifier les régimes de médicaments et de test administrés
par le patient, ce procédé comprenant les étapes suivantes exécutées par l'appareil
portatif :
la réception de données provenant d'un patient, ces données du patient comprenant
au moins un des types de données suivants : données physiologiques, données pathophysiologiques,
données biologiques, données psychologiques, données neuropsychologiques, données
du comportement ;
l'évaluation de la sévérité des données du patient reçues ;
l'incitation du patient à exécuter un test administré par le patient si les données
du patient reçues sont évaluées comme étant au-dessus d'un niveau seuil de sévérité
;
la réception des résultats de test provenant du test administré par le patient ; et
la communication des résultats de test reçus provenant du test administré par le patient
à un fournisseur de soins de santé via un réseau de communication.
27. Procédé selon la revendication 26, comprenant en outre les étapes consistant à:
évaluer la sévérité des résultats de test reçus provenant du test administré par le
patient ;
modifier le régime de médicaments administré par le patient si les résultats de test
reçus provenant du test administré par le patient sont évalués comme étant au-dessus
d'un niveau seuil de sévérité ; et à
communiquer au patient le régime modifié de médicaments administré par le patient.
28. Procédé selon la revendication 27, comprenant en outre l'étape consistant à communiquer
le régime modifié de médicaments administré par le patient à un fournisseur de soins
de santé via un réseau de communication.
29. Procédé selon la revendication 27, comprenant en outre l'étape consistant à communiquer
le régime modifié de médicaments administré par le patient à un système de traitement
des données situé à distance, via un réseau de communications.
30. Procédé selon la revendication 26, comprenant en outre l'étape consistant à recevoir
du patient des informations sur l'observance du patient des régimes de médicaments
et de test administrés par le patient pendant une période de temps précédente.
31. Procédé selon la revendication 26, comprenant en outre l'étape consistant à communiquer
automatiquement les données du patient reçues à un fournisseur de soins de santé via
un réseau de communication si les données du patient sont évaluées comme étant au-dessus
d'un niveau seuil de sévérité.
32. Procédé selon la revendication 29, comprenant en outre l'étape consistant à communiquer
au patient des informations concernant le dosage des médicaments en réponse à la détermination
que le patient n'a pas observé le régime de médicaments pendant la période de temps
précédente.
33. Procédé selon la revendication 26, dans lequel les données du patient reçues comprennent
en outre au moins soit des informations sur un symptôme supra-thérapeutique ressenti
par le patient, soit des informations sur un symptôme sub-thérapeutique ressenti par
le patient.
34. Appareil pour surveiller le traitement de la maladie d'un patient, cette maladie étant
sélectionnée parmi le groupe comprenant l'asthme, la chimiothérapie anticancéreuse,
la dépression, l'hypertension artérielle, les troubles épileptiques et la thrombose,
le traitement de la maladie comprenant un régime de médicaments administré par le
patient et un régime administré par le patient pour un test qui surveille l'efficacité
du régime de médicaments, cet appareil comprenant
un processeur ;
une interface utilisateur en communication avec ce processeur ;
un code machine exécutable par le processeur, qui reçoit et stocke les données provenant
d'un patient, ces données du patient comprenant au moins un des types de données suivants
: données physiologiques, données pathophysiologiques, données biologiques, données
psychologiques, données neuropsychologiques, données du comportement ;
un code machine exécutable par le processeur qui évalue la sévérité des données du
patient reçues ;
un code machine exécutable par le processeur qui incite le patient, via l'interface
utilisateur, à exécuter un test administré par le patient si les données du patient
reçues sont évaluées comme étant au-dessus d'un niveau seuil de sévérité ;
un code machine exécutable par le processeur, qui reçoit et stocke les résultats de
test provenant du test administré par le patient ; et
un code machine exécutable par le processeur qui communique les résultats de test
reçus provenant du test administré par le patient à un fournisseur de soins de santé
via un réseau de communication.
35. Appareil selon la revendication 34, comprenant en outre :
un code machine exécutable par le processeur, qui évalue la sévérité des résultats
de test reçus provenant du test administré par le patient ;
un code machine exécutable par le processeur qui modifie le régime de médicaments
administré par le patient si les résultats de test reçus provenant du test administré
par le patient sont évalués comme étant au-dessus d'un niveau seuil de sévérité ;
et
un code machine exécutable par le processeur qui communique au patient le régime modifié
de médicaments administré par le patient.
36. Appareil selon la revendication 35, comprenant en outre un code machine exécutable
par le processeur qui communique le régime modifié de médicaments administré par le
patient à un fournisseur de soins de santé via un réseau de communication.
37. Appareil selon la revendication 35, comprenant en outre un code machine exécutable
par le processeur qui communique le régime modifié de médicaments administré par le
patient à un système de traitement des données situé à distance via un réseau de communication.
38. Appareil selon la revendication 34, comprenant en outre un code machine exécutable
par le processeur qui reçoit et stocke des informations fournies par le patient sur
l'observance du patient des régimes de médicaments et de test administrés par le patient
pendant une période de temps précédente.
39. Appareil selon la revendication 34, comprenant en outre un code machine exécutable
par le processeur qui communique automatiquement les données du patient reçues à un
fournisseur de soins de santé via un réseau de communication si les données du patient
sont évaluées comme étant au-dessus d'un niveau seuil de sévérité.
40. Appareil selon la revendication 37, comprenant en outre un code machine exécutable
par le processeur qui communique au patient des informations concernant le dosage
des médicaments en réponse à la détermination que le patient n'a pas observé le régime
de médicaments pendant la période de temps précédente.
41. Produit programme informatique pouvant être chargé directement dans la mémoire interne
d'un calculateur numérique comprenant des parties de code de logiciel pour exécuter
les étapes de la revendication 1, et de toute revendication dépendante de celle-ci,
lorsque ledit produit tourne sur un ordinateur.
42. Produit programme informatique pouvant être chargé directement dans la mémoire interne
d'un calculateur numérique comprenant des parties de code de logiciel pour exécuter
les étapes de la revendication 26, et de toute revendication dépendante de celle-ci,
lorsque ledit produit tourne sur un ordinateur.